DCIS (ductal carcinoma in situ) is a common pre-stage for breast cancer. The goal of this clinical trial is to learn if FAPI-PET/MRI (an imaging technique with a weakly radioactive drug) helps to diagnose hidden invasive breast cancer in participants with DCIS. The main question it aims to answer is:
How good can FAPI-PET/MRI diagnose hidden invasive breast cancer in DCIS?
Researchers will compare FAPI-PET/MRI results to tissue samples obtained from surgery treatment to see if the FAPI-PET/MRI images show invasive breast cancer certainly.
Participants will
* receive the radioactive drug and lie in an imaging device for 45 minutes including a break
* visit the clinic once again for a checkup and test

Start Date10 Sep 2024

Sponsor / Collaborator

Universität Leipzig

NCT05898854 / RecruitingPhase 2IIT

[68Ga]Ga-FAPI PET/CT: The Dagnostic Accuracy for Primary Staging and Re-staging After Chemotherapy in Patients With Gastric and Gastro-esophageal Junctional Cancer

Twenty (n=20) patients with gastric cancer or gastro-esophageal junctional cancer will undergo FAPI PET/CTs in addition to routing diagnostic workup (including FDG PET/CT) at primary staging and restaging.
The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Start Date15 Feb 2024

Sponsor / Collaborator

Aalborg University Hospital

NCT05903807 / RecruitingPhase 2IIT

[68Ga]Ga-FAPI-46 PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging of Patients With Ovarian Cancer

Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging.
The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Start Date17 Nov 2023

Sponsor / Collaborator

Aalborg University Hospital

100 Clinical Results associated with [68Ga]FAPI-46

100 Translational Medicine associated with [68Ga]FAPI-46

100 Patents (Medical) associated with [68Ga]FAPI-46

Literatures (Medical) associated with [68Ga]FAPI-46

26 Nov 2024·CHEMICAL & PHARMACEUTICAL BULLETIN

GMP-Compliant Automated Radiolabeling and Quality Controls of [<sup>68</sup>Ga]Ga-FAPI-46 for Fibroblast Activation Protein-Targeted PET Imaging in Clinical Settings

Article

Author: Fersing, Cyril ; Rubira, Léa ; Vanney, Johanne ; Fouillet, Juliette ; Torchio, Jade

In nuclear medicine, molecular imaging of the tumor microenvironment using radiopharmaceuticals (RPs) targeting cancer-associated fibroblasts is gaining significant interest. Among these RPs, [⁶⁸Ga]Ga-FAPI-46 for positron emission tomography (PET) imaging is frequently used in clinical research protocols. To ensure that the production of this RP complies with good manufacturing practices, process automation is widely adopted. In this context, an automated method for preparing [⁶⁸Ga]Ga-FAPI-46 was designed using a GAIA^® synthesizer. Additionally, a HPLC method was developed and validated to determine the radiochemical purity (RCP) of [⁶⁸Ga]Ga-FAPI-46 and ensure product quality. The validated HPLC method showed excellent repeatability, with coefficients of variation (%CV) for RCP and retention time (t_R) below 0.03 and 0.16%, respectively, across 10 measurements. The radiochemical identification of [⁶⁸Ga]Ga-FAPI-46 showed comparable tr values to [^natGa]Ga-FAPI-46 (6.65 and 6.59 min, respectively). The limits of detection (LOD) and quantification (LOQ) were 79 and 42 kBq/mL, respectively, with a linear detector response between 62.9 and 0.08 MBq/mL (R² = 0.9999). The method proved robust, tolerating minor variations in mobile phase flow rate and composition. This validated radio-HPLC method can be used routinely for the quality control of [⁶⁸Ga]Ga-FAPI-46. Finally, three RP validation batches were produced using the automated method described and subjected to multiple quality controls. All three synthesis products met the expected specifications, notably regarding appearance, chemical and isotope identification, pH, sterility, stability, and radionuclidic and radiochemical purity.

01 Jul 2024·MOLECULAR PHARMACEUTICS

Enhanced Detection of Early Pulmonary Fibrosis Disease Using ⁶⁸Ga-FAPI-LM3 PET

Article

Author: Dai, Yaqing ; Lin, Qin ; Chen, Jianhao ; Sun, Long ; Zhao, Liang ; Su, Guoqiang ; Zhou, Yangfan ; Chen, Haojun ; Pang, Yizhen ; Wu, Hua ; Luo, Doudou

Early detection of pulmonary fibrosis is a critical yet insufficiently met clinical necessity. This study evaluated the effectiveness of FAPI-LM3, a ⁶⁸Ga-radiolabeled heterobivalent molecular probe that targets fibroblast activating protein (FAP) and somatostatin receptor 2 (SSTR2), in the early detection of pulmonary fibrosis, leveraging its potential for early disease identification. A bleomycin-induced early pulmonary fibrosis model was established in C57BL/6 mice for 7 days. FAP and SSTR2 expression levels were quantitatively assessed in human idiopathic pulmonary fibrosis lung tissue samples and bleomycin-treated mouse lung tissues by using western blotting, real-time quantitative PCR (RT-qPCR), and immunofluorescence techniques. The diagnostic performance of FAPI-LM3 was investigated by synthesizing monomeric radiotracers ⁶⁸Ga-FAPI-46 and ⁶⁸Ga-DOTA-LM3 alongside the heterobivalent probe ⁶⁸Ga-FAPI-LM3. These imaging radiopharmaceuticals were used in small-animal PET to compare their uptake in fibrotic and normal lung tissues. Results indicated significant upregulation of FAP and SSTR2 at both RNA and protein levels in fibrotic lung tissues compared with that in normal controls. PET imaging demonstrated significantly enhanced uptake of the ⁶⁸Ga-FAPI-LM3 probe in fibrotic lung tissues, with superior visual effects compared to monomeric tracers. At 60 min postinjection, early stage fibrotic tissues (day 7) demonstrated low-to-medium uptake of monomeric probes, including ⁶⁸Ga-DOTA-LM3 (0.45 ± 0.04% ID/g) and ⁶⁸Ga-FAPI-46 (0.78 ± 0.09% ID/g), whereas the uptake of the heterobivalent probe ⁶⁸Ga-FAPI-LM3 (1.90 ± 0.10% ID/g) was significantly higher in fibrotic lesions than in normal lung tissue. Blockade experiments confirmed the specificity of ⁶⁸Ga-FAPI-LM3 uptake, which was attributed to synergistic targeting of FAP and SSTR2. This study demonstrates the potential of ⁶⁸Ga-FAPI-LM3 for early pulmonary fibrosis detection via molecular imaging, offering significant benefits over monomeric tracers ⁶⁸Ga-FAPI-46 and ⁶⁸Ga-DOTA-LM3. This strategy offers new possibilities for noninvasive and precise early detection of pulmonary fibrosis.

01 Mar 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

PET Imaging of Fibroblast Activation Protein in Various Types of Cancer Using⁶⁸Ga-FAP-2286: Comparison with¹⁸F-FDG and⁶⁸Ga-FAPI-46 in a Single-Center, Prospective Study

Article

Author: Meng, Tinghua ; Zhang, Jingjing ; Sun, Long ; Pang, Yizhen ; Zhao, Liang ; Chen, Haojun ; Xu, Weizhi ; Lin, Qin ; Wu, Hua ; Chen, Xiaoyuan

PET imaging that targets fibroblast activation protein (FAP) on the surface of cancer-associated fibroblasts has yielded promising tumor diagnostic results. FAP-2286 contains cyclic peptides as FAP-binding motifs to optimize tumor retention compared with the small-molecule FAP inhibitor (FAPI) series (FAPI-04/46). The aim of this study was to evaluate the diagnostic accuracy of ⁶⁸Ga-FAP-2286 to detect primary and metastatic lesions in patients with various types of cancer, compared with ¹⁸F-FDG and ⁶⁸Ga-FAP-2286. Methods: Sixty-four patients with 15 types of cancer underwent ⁶⁸Ga-FAP-2286 PET/CT for initial assessment or detection of recurrence. For comparison, 63 patients underwent paired ⁶⁸Ga-FAP-2286 and ¹⁸F-FDG PET/CT and 19 patients underwent paired ⁶⁸Ga-FAP-2286 and ⁶⁸Ga-FAPI-46 PET/CT. Lesion uptake was quantified as SUV_max and tumor-to-background ratio. The Wilcoxon matched-pairs signed-rank test was used to compare SUV_max between PET modalities, and the McNemar test was used to compare lesion detectability. Results: Uptake of ⁶⁸Ga-FAP-2286 was significantly higher than that of ¹⁸F-FDG in primary tumors (median SUV_max, 11.1 vs. 6.9; P < 0.001), lymph node metastases (median SUV_max, 10.6 vs. 6.2; P < 0.001), and distant metastases, resulting in improved image contrast and lesion detectability. All primary tumors (46/46) were clearly visualized by ⁶⁸Ga-FAP-2286 PET/CT, whereas 9 of the 46 lesions could not be visualized by ¹⁸F-FDG PET/CT. The lesion detection rate of ⁶⁸Ga-FAP-2286 PET/CT was superior to that of ¹⁸F-FDG PET/CT for involved lymph nodes (98% [105/107] vs. 85% [91/107], P = 0.001) and bone and visceral metastases (95% [162/171] vs. 67% [114/171], P < 0.001). ⁶⁸Ga-FAP-2286 yielded tumor uptake and lesion detection rates similar to those of ⁶⁸Ga-FAPI-46 in a subcohort of 19 patients. Conclusion: ⁶⁸Ga-FAP-2286 is a promising FAP-inhibitor derivative for safe cancer diagnosis, staging, and restaging. It may be a better alternative to ¹⁸F-FDG for the cancer types that exhibit low-to-moderate uptake of ¹⁸F-FDG, which include gastric, pancreatic, and hepatic cancers. In addition, ⁶⁸Ga-FAP-2286 and ⁶⁸Ga-FAPI-46 yielded comparable clinical results.

News (Medical) associated with [68Ga]FAPI-46

12 May 2023

·www.prnewswire.com

First Patient Imaged in SOFIE's 18F-FAPI Phase 2 trial

DULLES, Va., May 12, 2023 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has dosed and imaged the first patient with [18F]FAPI-74 in its US Clinical Trial of flourine-18 labeled Fibroblast Activation Protein Inhibitor (FAPI). This study is a Phase 2, Multicenter, Non-randomized Study of [18F]FAPI-74 PET for imaging patients with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer (NCT05641896). The clinical trial comes after the US FDA granted SOFIE an active IND in support of this study in November of 2022. The study was launched at its first site in Boston under Principal Investigator, Shadi Esfahani, MD, MPH. Additional sites are in the process of activation and anticipated to begin recruitment in the coming weeks. Sherly Mosessian, Ph.D., SOFIE's Chief Scientific Officer, commented, "We are thrilled to see the launch of the study and imaging of the first patient in this prospective study. Tremendous promise exists in diagnostic and companion diagnostic use of FAPI family of compounds, especially in gastrointestinal cancers. Flourine-18 labeled FAPI opens up many possibilities in FAP targeting, and we are excited to be driving this product forward to unlock more of its potential." The commitment to improving patient care through utilization of radiopharmaceuticals for imaging and therapy is a professional and personal mission of SOFIE's. Frank Valla, SOFIE's Director of Clinical Development and FAPI CMC lead, added, "The promise of FAP targeting in gastrointestinal cancers and the recognition of this important milestone for patient care brings great excitement to the field as well as sense of personal fulfillment after having lost my father to Colorectal Cancer in 2007." This study is the second SOFIE FAPI product in a clinical study. SOFIE is currently conducting a Phase 2 clinical study with the lead Galium-68 labelled FAPI product, [68Ga]FAPI-46, in Pancreatic Ductal Adenocarcinoma patients (NCT05262855). About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, contact [email protected]. About FAPI Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University, quinoline-based PET tracers that act as FAP inhibitors (FAPI) have shown encouraging results in pre-clinical and clinical studies. SOFIE has licensed the rights for diagnostic and companion diagnostic use of FAPI family of compounds from Heidelberg University. About [18F]FAPI-74 [18F]FAPI-74 is the lead Fluorine-18 radiolabeled PET tracer of FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety and biodistribution profile amenable for detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners. Media Contact: Dawn Allen [email protected] SOURCE Sofie Biosciences

Phase 2IND

17 Jan 2023

·www.prnewswire.com

IND granted for FAP targeting therapeutic in SOFIE partnership

DULLES, Va., Jan. 17, 2023 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, will be supporting, through companion diagnostic [68Ga]FAPI-46 PET, Yantai LNC Biotechnology's recently FDA accepted clinical study. On Jan 6th, 2023 Yantai LNC Biotechnology received FDA clearance to proceed with a Phase 1 clinical study of 177Lu-LNC1004 injection, targeting fibroblast activation protein (FAP). The study accepted as part of the FDA IND review is a Phase I, open label study of the safety and dosimetry of a 4-dose regimen of escalating doses of 177Lu-LNC1004 injection in adult patients with advanced FAP-positive solid tumors. As the companion diagnostic agent of 177Lu-LNC1004 Injection, [68Ga]FAPI-46 PET will be used to screen subjects and assess therapeutic effect. Yantai obtained access to [68Ga]FAPI-46 through a letter of cross reference to SOFIE Biosciences' IND along with corresponding precursor and reference standard for use. Prof. Xiaoyuan (Shawn) Chen, co-founder of Yantai LNC Biotechnology and editor-in-chief of the journal Theranostics, stated, "we appreciate the opportunity to work closely with SOFIE in pushing the long-acting FAPI formula 177Lu-LNC1004 forward. Applying Evans blue derivatives to modify pharmacokinetics and pharmacodynamics is a platform technology Yantai LNC Biotechnology has successfully implemented to multiple radioligands such as FAP inhibitors." Sherly Mosessian, Ph.D., SOFIE's Chief Scientific Officer, added, "as license holders of FAPI family of compounds for diagnostic and companion diagnostic use, we are excited to support this very promising study by having [68Ga]FAPI-46 serve as a companion diagnostic tool for patient selection and treatment monitoring with 177Lu-LNC1004. This highlights the power of theranostics in utilizing the same target, FAP, for imaging and treatment interventions." The study is expected to enroll up to 24 subjects in advanced solid tumors that show high level of FAP expression detected by [68Ga]FAPI-46 and will establish the recommended expansion phase dose with 177Lu-LNC1004. Site feasibility and selection is complete and the study is expected to launch in Singapore Q2 2023. About Yantai LNC Biotechnology Yantai LNC Biotechnology Singapore Pte. Ltd. is a wholly owned subsidiary of Yantai Dongcheng Pharmaceutical Group. As the unique innovative nuclear medicine development platform in Dongcheng Group, Yantai LNC Biotech is committed to radionuclide diagnosis and therapy innovation. For more information, contact [email protected]. About 177Lu-LNC1004 177Lu-LNC1004 is a fibroblast activation protein inhibitor (FAPI) modified with Evans blue (EB) and a metal chelator (DOTA), radiolabeled with beta-emitting radionuclide lutetium Lu-177. As a first-in-class drug the FAP-targeting probe will be used to treat adult patients with advanced FAP-positive solid tumors. About FAPI Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University Hospital (UKHD), quinoline-based PET tracers that act as FAP inhibitors (FAPI) have shown encouraging results in pre-clinical and clinical studies. SOFIE has licensed the rights for diagnostic and companion diagnostic use of FAPI family of compounds from Heidelberg University. [68Ga]FAPI-46 is the lead gallium-68 and [18F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer of FAPI family of compounds. They have demonstrated favorable dosimetry, avidity, safety and biodistribution profile amenable for detection of FAP-expressing cells in patients with various cancers. Both products have active INDs for Phase 2 studies in cancers of the digestive system. About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, contact [email protected]. SOURCE SOFIE

Phase 1INDPhase 2

29 Nov 2022

·www.prnewswire.com

SOFIE granted IND for 18F-FAPI in Phase 2 study

DULLES, Va., Nov. 29, 2022 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received Investigational New Drug (IND) clearance to proceed with clinical study of [18F]FAPI-74, its lead fluorine-18 labelled Fibroblast Activation Protein Inhibitor (FAPI) product. The study accepted as part of the FDA IND review is for a Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in patients with Gastrointestinal Cancers. The cancer types included as part of this study are: gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer and colorectal cancer. SOFIE is currently conducting a Phase 2 clinical study with the lead Galium-68 labelled FAPI product, [68Ga]FAPI-46, in Pancreatic Ductal Adenocarcinoma patients (NCT05262855). The filing for the [18F]FAPI-74 IND expands SOFIE's product portfolio and provides opportunities for FAP targeted diagnostics using both Gallium-68 and Fluorine-18 lead products. "Our team at Heidelberg are very proud of this fluorine-18 FAPI milestone", stated Professor Uwe Haberkorn, whose team led the discovery and development of FAPI theranostics. Sherly Mosessian, Ph.D, SOFIE's Chief Scientific Officer, added, "Fluorine-18 FAPI with the longer half-life will open up many opportunities in diagnostic and companion diagnostic utility of FAP targeting. We are excited to demonstrate the performance of [18F]FAPI-74 in this Phase 2 study for a major area of unmet need in gastrointestinal cancers." In addition to the existing and upcoming sponsored trials, SOFIE engages with academic and industry partners through the FAPI global outreach program to expand access for investigational use of FAPI products. The [18F]FAPI-74 granted IND will further advance these efforts. About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, contact [email protected]. About FAPI Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University Hospital (UKHD), quinoline-based PET tracers that act as FAP inhibitors (FAPI) have shown encouraging results in pre-clinical and clinical studies. SOFIE has licensed the rights for diagnostic and companion diagnostic use of FAPI family of compounds from Heidelberg University. About [18F]FAPI-74 [18F]FAPI-74 is the lead Fluorine-18 radiolabeled PET tracer of FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety and biodistribution profile amenable for detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners. SOURCE SOFIE

Phase 2IND

100 Deals associated with [68Ga]FAPI-46

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrooesophageal junction cancer	Phase 2	DK	Aalborg University Hospital	15 Feb 2024
Ovarian Cancer	Phase 2	DK	Aalborg University Hospital	17 Nov 2023
Colitis, Ulcerative	Phase 2	NL	Academic Medical Center University of Amsterdam	31 Aug 2023
Crohn Disease	Phase 2	NL	Academic Medical Center University of Amsterdam	31 Aug 2023
Fibrosis	Phase 2	NL	Academic Medical Center University of Amsterdam	31 Aug 2023
Adenomatous Polyposis Coli	Phase 2	US	Sofie Biosciences, Inc.	02 May 2022
Pancreatic Ductal Adenocarcinoma	Phase 2	US	Sofie Biosciences, Inc.	02 May 2022
Alveolitis, Extrinsic Allergic	Phase 1	US	University of California, Los Angeles	16 Nov 2021
Idiopathic Interstitial Pneumonias	Phase 1	US	University of California, Los Angeles	16 Nov 2021
Pneumoconiosis	Phase 1	US	University of California, Los Angeles	16 Nov 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2024	Not Applicable	Urothelial Carcinoma of the Urinary Bladder	-	[18F]F-FAPI-74 PET/CT	nbvtasfqqj(racqosekgq) = pglqxjsuiz smihaywuva (spgrylidya )	-	09 Jun 2024
SNMMI2023	Not Applicable	Visible Lesion	-	68Ga-FAPI-4618F-FDGPI-46 (18F-FDG-PET)	vgcoljuxwz(ktqgmmrglq) = the average 68Ga-FAPI-46/18-FDG average ratio was higher in LC than in benign lesions (3.64 +/- 1.59 versus 1.89 +/- 0.32) rhijpwjuir (wuwtkyzavx ) View more	-	28 Aug 2023
SNMMI2023	Not Applicable	-	-	68Ga-FAPI-46	ccasyfsqje(oetblibzom) = yjcnyvhnyl kfvdwrsvnx (ropztbmndz )	-	28 Aug 2023
SNMMI2023	Phase 2	Adenomatous Polyposis Coli FAP expression	91	68Ga-FAPI-4618F-FDGPI-46 (18F-FDG PET/CT)	umcbbrwlud(kzuittvytw) = yygyxedday afzyxhxujv (jikbeykkas )	Positive	28 Aug 2023
SNMMI2023	Not Applicable	-	-	[68Ga]Ga-FAPI-46	eivazlfbmo(efkzzmtleu) = pzoajcjmhb vbnvytdqhd (icxtpdjmwf ) View more	-	28 Aug 2023

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