Background:
Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in certain cancer cells. [18F]FAPI-74 is a new tracer-a substance that is injected into a person s body before an imaging scan. Researchers believe that [18F]FAPI-74 may be able to highlight FAP enzymes more effectively than approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.
Objective:
To see if [18F]FAPI-74 PET scans are as good or better than other methods for detecting certain cancers.
Eligibility:
People aged 18 years or older with cancer in 1 of these places: the ducts of the pancreas, liver, gallbladder, or small intestine; stomach; bladder; ovaries; or adrenal glands. They must be enrolled in an NIH treatment study for their cancer.
Design:
Participants will have 2 baseline scans: 1 with [18F]FAPI-74; 1 with an approved tracer.
The [18F]FAPI-74 will be infused through a tube attached to a needle inserted into a vein. About 1 hour later, the participant will undergo 1 or more imaging scans.
Within 1 week, participants will undergo the same scanning procedures with the approved tracer.
If the baseline scan with [18F]FAPI-74 shows the tumors, scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scans with the regular tracer also showed tumors, this scan will be repeated within the same week as the repeated [18F]FAPI-74 scans. If either type of scan showed no tumors, that scan will not be repeated.
If the participant s cancer progresses within 2 years, both types of scan may be repeated.
Follow-up calls will continue for 2 years.

Start Date21 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT06568783 / Not yet recruitingPhase 2IIT

Evaluation of Patients With Refractory Dermatomyositis Using [18F]- Fibroblast Activation Protein Inhibitor-74 (FAPI-74) PET/MRI Imaging

This study proposes the use of a PET isotope, [18F]-Fibroblast Activation Protein Inhibitor-74, for a prospective single-center, single-arm study using MRI imaging for participants with Refractory Dermatomyostitis.

Start Date01 Oct 2024

Sponsor / Collaborator

Stanford University

NCT06413355 / RecruitingPhase 1IIT

Fibroblast Activating Protein (FAP) PET/CT in Adults with Fibrotic Conditions

This protocol is intended as a basket protocol designed to evaluate the use of Fibroblast Activating Protein (FAP) PET/CT in imaging the presence of fibrosis caused by a variety of medical conditions where fibrosis is believed to lead to pathological effects and poor prognosis.

Start Date16 Jul 2024

Sponsor / Collaborator

Abramson Cancer Center

100 Clinical Results associated with [18F]FAPI-74

100 Translational Medicine associated with [18F]FAPI-74

100 Patents (Medical) associated with [18F]FAPI-74

Literatures (Medical) associated with [18F]FAPI-74

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

Initial Evaluation of [¹⁸F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions.

Article

Author: Kurokawa, Yukinori ; Giesel, Frederik L ; Kamiya, Takashi ; Kobayashi, Shogo ; Kimura, Toru ; Kato, Hiroki ; Shimazu, Kenzo ; Watabe, Tadashi ; Mori, Yuriko ; Abe, Kaori ; Cardinale, Jens ; Miyake, Tomohiro ; Eguchi, Hidetoshi ; Naka, Sadahiro ; Shintani, Yasushi ; Doki, Yuichiro ; Inohara, Hidenori ; Tatsumi, Mitsuaki

The ¹⁸F-labeled fibroblast activation protein inhibitor (FAPI) [¹⁸F]FAPI-74 has the benefit of a higher synthetic yield and better image resolution than ⁶⁸Ga-labeled FAPI. We preliminarily evaluated the diagnostic performance of [¹⁸F]FAPI-74 PET in patients with various histopathologically confirmed cancers or suspected malignancies. Methods: We enrolled 31 patients (17 men and 14 women) with lung cancer (n = 7), breast cancer (n = 5), gastric cancer (n = 5), pancreatic cancer (n = 3), other cancers (n = 5), and benign tumors (n = 6). Twenty-seven of the 31 patients were treatment-naïve or preoperative, whereas recurrence was suspected in the remaining 4 patients. Histopathologic confirmation was obtained for the primary lesions of 29 of the 31 patients. In the remaining 2 patients, the final diagnosis was based on the clinical course. [¹⁸F]FAPI-74 PET scanning was performed 60 min after the intravenous injection of [¹⁸F]FAPI-74 (240 ± 31 MBq). The [¹⁸F]FAPI-74 PET images were compared between the primary or local recurrent lesions of malignant tumors (n = 21) and nonmalignant lesions (n = 8: type-B1 thymomas, granuloma, solitary fibrous tumor, and postoperative or posttherapeutic changes). The uptake and number of detected lesions on [¹⁸F]FAPI-74 PET were also compared with those on [¹⁸F]FDG PET for available patients (n = 19). Results: [¹⁸F]FAPI-74 PET showed higher uptake in primary lesions of various cancers than in nonmalignant lesions (median SUV_max, 9.39 [range, 1.83-25.28] vs. 3.49 [range, 2.21-15.58]; P = 0.053), but some of the nonmalignant lesions showed high uptake. [¹⁸F]FAPI-74 PET also showed significantly higher uptake than [¹⁸F]FDG PET (median SUV_max, 9.44 [range, 2.50-25.28] vs. 5.45 [range, 1.22-15.06] in primary lesions [P = 0.010], 8.86 [range, 3.51-23.33] vs. 3.84 [range, 1.01-9.75] in lymph node metastases [P = 0.002], and 6.39 [range, 0.55-12.78] vs. 1.88 [range, 0.73-8.35] in other metastases [P = 0.046], respectively). In 6 patients, [¹⁸F]FAPI-74 PET detected more metastatic lesions than [¹⁸F]FDG PET. Conclusion: [¹⁸F]FAPI-74 PET showed higher uptake and detection rates in primary and metastatic lesions than did [¹⁸F]FDG PET. [¹⁸F]FAPI-74 PET is a promising novel diagnostic modality for various tumors, especially for precise staging before treatment, including characterization of tumor lesions before surgery. Moreover, ¹⁸F-labeled FAPI ligand might serve a higher demand in clinical care in the future.

17 May 2023·Cancers

Head-to-Head Intra-Individual Comparison of Biodistribution and Tumor Uptake of [¹⁸F]FAPI-74 with [¹⁸F]FDG in Patients with PDAC: A Prospective Exploratory Study.

Article

Author: Fernandez, Rene ; Soza-Ried, Cristian ; Mori, Yuriko ; Kramer, Vasko ; Amaral, Horacio ; Pinto, Claudio ; Choyke, Peter L ; Antke, Christina ; Badinez, Leonardo ; Schmitt, Dominik ; Novruzov, Emil ; Mamlins, Eduards ; Dabir, Mardjan ; Giesel, Frederik L

BACKGROUNDRadiolabeled fibroblast activation protein (FAP) ligands, a novel class of tracers for PET/CT imaging, have demonstrated very promising results in various oncological, as well as in some benign, diseases with long-term potential to supplant the current pan-cancer agent [¹⁸F]FDG in some cancer types. Pancreatic ductal carcinoma (PDAC) belongs to the group of epithelial malignancies with a strong so-called "desmoplastic reaction", leading to a prominent tumor stroma with cancer-associated fibroblasts that exhibit a marked overexpression of fibroblast activation protein (FAP). The first clinical experiences in PDAC with ⁶⁸Ga-labeled FAP ligands suggested superior sensitivity to [¹⁸F]FDG. However, there is limited data with ¹⁸F-labeled FAP derivatives, i.e. [¹⁸F]FAPI-74, yet prospective single- and multicenter trials are already ongoing. In this proof-of-concept study, we sought to evaluate the biodistribution, tumor uptake, and lesion detectability in patients with PDAC using [¹⁸F]FAPI-74 PET/CT as compared to [¹⁸F]FDG PET/CT scans for staging.METHODSThis study includes 7 patients (median age 69) who underwent both [¹⁸F]FDG PET/CT with contrast-enhancement and [¹⁸F]FAPI-74 PET with low-dose CT for primary staging (n = 3) and therapy response control after neoadjuvant (n = 1) or re-staging after palliative therapy (n = 3). The mean interval between PET scans was 11 ± 4 days (range 1-15 days). The [¹⁸F]FDG and [¹⁸F]FAPI-74 PET/CT scans were acquired at 64 ± 4.1 min (range 61-91 min) and 66.4 ± 6.3 min (range 60-76 min), respectively, after administration of 200 ± 94 MBq (range 79-318 MBq) and 235 ± 88 MBq (range 90-321 MBq), respectively. Quantification of tracer uptake was determined with SUV_max and SUV_mean. Furthermore, the tumor-to-background ratio (TBR) was derived by dividing the SUV_max of tumor lesions by the SUV_max of adipose tissue, skeletal muscle, and blood pool.RESULTSOverall, 32 lesions were detected in 7 patients including primary (n = 7), lung (n = 7), bone (n = 3), lymph node (n = 13), and peritoneal metastases (n = 2). [¹⁸F]FAPI-74 detected 22% more lesions compared with [¹⁸F]FDG with a better TBR and visual lesion delineation. In one patient the primary lesion could be detected unequivocally with [¹⁸F]FAPI-74 but was missed by [¹⁸F]FDG imaging. Altogether, most of the lesions demonstrated markedly elevated uptake of [¹⁸F]FAPI-74 with a simultaneous lower uptake in the background, providing a very high visual contrast.CONCLUSIONTo the best of our knowledge, this is the first, prospective, intra-individual investigation comparing [¹⁸F]FAPI-74 with [¹⁸F]FDG imaging in PDAC with encouraging results. These pivotalresults supporta larger, multicentric, prospective study to determine the value of [¹⁸F]FAPI-74 in detecting and staging PDAC in comparison with current standard of care imaging.

30 Jun 2021·Journal of Labelled Compounds and RadiopharmaceuticalsQ4 · MEDICINE

Fully automated production of the fibroblast activation protein radiotracer [¹⁸F]FAPI‐74

Q4 · MEDICINE

Article

Author: Bylund, Lovisa ; Samén, Erik ; Dahl, Kenneth ; Moein, Mohammad Mahdi ; Jussing, Emma ; Tran, Thuy

We report herein an efficient and fully automated protocol for the radiosynthesis of [18F]FAPI‐74, a new positron emission tomography (PET) radiopharmaceutical for in vivo detection of the fibroblast activation protein. [18F]FAPI‐74 was synthesized via a rapid [18F]aluminum fluoride coordination reaction, which was first developed on the flexible GE TRACERLab FX2N (FXN) platform and later translated to the cassette‐based module Trasis AllInOne (AIO). The results obtained with both modules were comparable in terms of yield and reproducibility. Automation of [18F]FAPI‐74 radiosynthesis on the FXN was carried out in 35 min with a radiochemical yield (RCY) of 18.5 ± 2.5% (n = 5, relative to starting [18F]fluoride). Method transfer to the AIO platform following minor optimizations allowed for the production of [18F]FAPI‐74 in an isolated RCY of 20 ± 2.5% [n = 3] with an overall synthesis time of 40 min. The radiochemical purity was greater than 95% for [18F]FAPI‐74, obtained from both modules. Overall, the protocol reliably provides a sterile and pyrogen‐free good manufacturing practice (GMP) compliant product of [18F]FAPI‐74 suitable for clinical PET imaging.

100 Deals associated with [18F]FAPI-74

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatomyositis	Phase 2	US	Stanford University	01 Oct 2024
Bile Duct Neoplasms	Phase 2	US	Sofie Biosciences, Inc.	28 Apr 2023
Colorectal Cancer	Phase 2	US	Sofie Biosciences, Inc.	28 Apr 2023
Hepatocellular Carcinoma	Phase 2	US	Sofie Biosciences, Inc.	28 Apr 2023
Pancreatic Ductal Adenocarcinoma	Phase 2	US	Sofie Biosciences, Inc.	28 Apr 2023
Stomach Cancer	Phase 2	US	Sofie Biosciences, Inc.	28 Apr 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	-	-	[18F]FAPI-74	jjkxqvpfdi(pqnpxhhobj) = julepuqpui vpxozhhwrz (rtnuoyakgx, 0.8)	-	28 Aug 2023

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