Preoperative localisation of parathyroid adenoma in patients with primary hyperparathyroidism with 4D-CT versus 18F-fluorocholine PET CT: A pilot randomised controlled trial.

Start Date01 May 2022

Sponsor / Collaborator-

NCT04895631

/ RecruitingPhase 3IIT

18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas

This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

Start Date30 Jun 2021

Sponsor / Collaborator

The University of California, San Francisco

EUCTR2019-002729-31-ES

/ Unknown statusPhase 4IIT

18F-fluorocholine PET/CT in primary hyperparathyroidism with negative preoperative localization - PET/CT in hyperparathyroidism

Start Date02 Mar 2020

Sponsor / Collaborator-

100 Clinical Results associated with 18F-Fluoromethylcholine

100 Translational Medicine associated with 18F-Fluoromethylcholine

100 Patents (Medical) associated with 18F-Fluoromethylcholine

Literatures (Medical) associated with 18F-Fluoromethylcholine

01 Sep 2023·European journal of nuclear medicine and molecular imaging

[¹⁸F]DCFPyL PET/CT versus [¹⁸F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study.

Article

Author: Tissot, Hubert ; García Vicente, Ana Maria ; Tamayo, Pilar ; Oprea-Lager, Daniela-Elena ; Blanc-Durand, Paul ; Vander Borght, Thierry ; Vierasu, Irina ; Rodríguez-Fernández, Antonio ; Chossat, Florence ; Drouet, Clément ; Merlin, Charles ; Robin, Philippe ; Maksud, Philippe ; García-Cañamaque, Lina ; Vallejo-Casas, Juan Antonio ; Hodolic, Marina ; Rousseau, Caroline ; Bouyeure, Anne-Charlotte ; Olivier, Pierre ; Mitjavila, Mercedes ; Bailliez, Alban ; Boos, Evelyne ; Gontier, Eric ; Mahmoud, Sinan Ben ; Gauthé, Mathieu

PURPOSEPrimary objective was to compare the per-patient detection rates (DR) of [¹⁸F]DCFPyL versus [¹⁸F]fluoromethylcholine positron emission tomography/computed tomography (PET/CT), in patients with first prostate cancer (PCa) biochemical recurrence (BCR). Secondary endpoints included safety and impact on patient management (PM).METHODSThis was a prospective, open label, cross-over, comparative study with randomized treatment administration of [¹⁸F]DCFPyL (investigational medicinal product) or [¹⁸F]fluoromethylcholine (comparator). Men with rising prostate-specific antigen (PSA) after initial curative therapy were enrolled. [¹⁸F]DCFPyL and [¹⁸F]fluoromethylcholine PET/CTs were performed within a maximum time interval of 12 days. DR was defined as the percentage of positive PET/CT scans identified by 3 central imaging readers. PM was assessed by comparing the proposed pre-PET/CT treatment with the local treatment", defined after considering both PET/CTs.RESULTSA total of 205 patients with first BCR after radical prostatectomy (73%; median PSA = 0.46 ng/ml [CI 0.16;27.0]) or radiation therapy (27%; median PSA = 4.23 ng/ml [CI 1.4;98.6]) underwent [¹⁸F]DCFPyL- and/or [¹⁸F]fluoromethylcholine -PET/CTs, between July and December 2020, at 22 European sites. 201 patients completed the study. The per-patient DR was significantly higher for [¹⁸F]DCFPyL- compared to [¹⁸F]fluoromethylcholine -PET/CTs (58% (117/201 patients) vs. 40% (81/201 patients), p < 0.0001). DR increased with higher PSA values for both tracers (PSA ≤ 0.5 ng/ml: 26/74 (35%) vs. 22/74 (30%); PSA 0.5 to ≤ 1.0 ng/ml: 17/31 (55%) vs. 10/31 (32%); PSA 1.01 to < 2.0 ng/ml: 13/19 (68%) vs. 6/19 (32%);PSA > 2.0: 50/57 (88%) vs. 39/57 (68%) for [¹⁸F]DCFPyL- and [¹⁸F]fluoromethylcholine -PET/CT, respectively). [¹⁸F]DCFPyL PET/CT had an impact on PM in 44% (90/204) of patients versus 29% (58/202) for [¹⁸F]fluoromethylcholine. Overall, no drug-related nor serious adverse events were observed.CONCLUSIONSThe primary endpoint of this study was achieved, confirming a significantly higher detection rate for [¹⁸F]DCFPyL compared to [¹⁸F]fluoromethylcholine, in men with first BCR of PCa, across a wide PSA range. [¹⁸F]DCFPyL was safe and well tolerated.

01 Aug 2015·Journal of Nuclear MedicineQ1 · MEDICINE

Prospective Comparison of ¹⁸F-Fluoromethylcholine Versus ⁶⁸Ga-PSMA PET/CT in Prostate Cancer Patients Who Have Rising PSA After Curative Treatment and Are Being Considered for Targeted Therapy

Q1 · MEDICINE

Article

Author: Fanti, Stefano ; Nguyen, Quoc ; van Leeuwen, Pim J ; Emmett, Louise ; Jagavkar, Raj ; Tarlinton, Lisa ; Morigi, Joshua J ; Fogarty, Gerald ; Kneebone, Andrew ; Ho, Bao ; Hruby, George ; Stricker, Phillip D ; Tang, Reuben ; Hickey, Adam

In prostate cancer with biochemical failure after therapy, current imaging techniques have a low detection rate at the prostate-specific antigen (PSA) levels at which targeted salvage therapy is effective. (11)C-choline and (18)F-fluoromethylcholine, though widely used, have poor sensitivity at low PSA levels. (68)Ga-PSMA (Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga-N,N'-bis[2-hydroxy-5-(carboxyethyl)benzyl]ethylenediamine-N,N'-diacetic acid]) has shown promising results in retrospective trials. Our aim was to prospectively compare the detection rates of (68)Ga-PSMA versus (18)F-fluoromethylcholine PET/CT in men who were initially managed with radical prostatectomy, radiation treatment, or both and were being considered for targeted therapy.METHODSA sample of men with a rising PSA level after treatment, eligible for targeted treatment, was prospectively included. Patients on systemic treatment were excluded. (68)Ga-PSMA, (18)F-fluoromethylcholine PET/CT, and diagnostic CT were performed sequentially on all patients between January and April 2015, and the images were assessed by masked, experienced interpreters. The findings and their impact on management were documented, together with the results of histologic follow-up when feasible.RESULTSIn total, 38 patients were enrolled. Of these, 34 (89%) had undergone radical prostatectomy and 4 (11%) had undergone radiation treatment. Twelve (32%) had undergone salvage radiation treatment after primary radical prostatectomy. The mean PSA level was 1.74 ± 2.54 ng/mL. The scan results were positive in 26 patients (68%) and negative with both tracers in 12 patients (32%). Of the 26 positive scans, 14 (54%) were positive with (68)Ga-PSMA alone, 11 (42%) with both (18)F-fluoromethylcholine and (68)Ga-PSMA, and only 1 (4%) with (18)F-fluoromethylcholine alone. When PSA was below 0.5 ng/mL, the detection rate was 50% for (68)Ga-PSMA versus 12.5% for (18)F-fluoromethylcholine. When PSA was 0.5-2.0 ng/mL, the detection rate was 69% for (68)Ga-PSMA versus 31% for (18)F-fluoromethylcholine, and when PSA was above 2.0, the detection rate was 86% for (68)Ga-PSMA versus 57% for (18)F-fluoromethylcholine. On lesion-based analysis, (68)Ga-PSMA detected more lesions than (18)F-fluoromethylcholine (59 vs. 29, P < 0.001). The tumor-to-background ratio in positive scans was higher for (68)Ga-PSMA than for (18)F-fluoromethylcholine (28.6 for (68)Ga-PSMA vs. 9.4 for (18)F-fluoromethylcholine, P < 0.001). There was a 63% (24/38 patients) management impact, with 54% (13/24 patients) being due to (68)Ga-PSMA imaging alone. Histologic follow-up was available for 9 of 38 patients (24%), and 9 of 9 (68)Ga-PSMA-positive lesions were consistent with prostate cancer ((68)Ga-PSMA was true-positive). The lesion positive on (18)F-fluoromethylcholine imaging and negative on (68)Ga-PSMA imaging was shown at biopsy to be a false-positive (18)F-fluoromethylcholine finding ((68)Ga-PSMA was true-negative).CONCLUSIONIn patients with biochemical failure and a low PSA level, (68)Ga-PSMA demonstrated a significantly higher detection rate than (18)F-fluoromethylcholine and a high overall impact on management.

01 Nov 2014·European Journal of Nuclear Medicine and Molecular Imaging

18F-Fluorocholine PET/CT for localization of hyperfunctioning parathyroid tissue in primary hyperparathyroidism: a pilot study

Article

Author: Lezaic, Luka ; Fettich, Jure ; Sever, Mojca Jensterle ; Kocjan, Tomaz ; Hocevar, Marko ; Rep, Sebastijan

PURPOSEPrimary hyperparathyroidism is a common endocrine disorder which is diagnosed biochemically and for which therapy is surgical. A prerequisite for minimally invasive surgery, which minimizes morbidity and cost, is accurate localization of the involved gland(s). The aim of this study was to evaluate the usefulness of (18)F-fluorocholine PET/CT for preoperative localization of hyperfunctioning parathyroid tissue.METHODS(18)F-Fluorocholine PET/CT and conventional parathyroid scintigraphic imaging consisting of (99m)Tc-sestaMIBI SPECT/CT, (99m)Tc-sestaMIBI dual-phase imaging and (99m)Tc-sestaMIBI/pertechnetate subtraction imaging were performed in 24 patients. The diagnostic performance of the imaging methods was compared against histology as the gold standard and postoperative serum Ca(2+) and iPTH values.RESULTSThe sensitivity and specificity of (18)F-fluorocholine PET/CT were 92% and 100%, respectively, in contrast to 49% and 100%, 46% and 100%, and 44% and 100% for (99m)Tc-sestaMIBI SPECT/CT, (99m)Tc-sestaMIBI/pertechnetate subtraction imaging and (99m)Tc-sestaMIBI dual-phase imaging, respectively. Combined conventional scintigraphic imaging had a sensitivity and specificity of 64% and 100%, respectively. The performance of (18)F-fluorocholine PET/CT was superior particularly in patients with multiple lesions or hyperplasia.CONCLUSION(18)F-Fluorocholine PET/CT appears to be a promising, effective imaging method for localization of hyperfunctioning parathyroid tissue.

News (Medical) associated with 18F-Fluoromethylcholine

21 Jul 2023

·www.globenewswire.com

Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer. The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023. Today’s announcement follows the May 2023 recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency to grant a marketing authorization for PYLCLARI® (piflufolastat (18F)) indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer – based on the Phase III PYTHON clinical trial conducted in Europe and the Phase III OSPREY and CONDOR clinical trials conducted in the U.S. Dr. Daniela E. Oprea-Lager| Assoc. Professor in Nuclear Medicine, MD PhD, Amsterdam UMC (lead author of the PYTHON Manuscript submitted to the European Journal of Nuclear Medicine and Molecular Imaging) commented: “Adequate restaging of patients with biochemically relapsed prostate cancer is essential for guiding clinicians on how to choose the optimal treatment strategy with the maximum benefit for the patients. PYTHON trial demonstrates the superiority of [18F]DCFPyL above [18F]fluoromethylcholine PET/CT paving the way towards individualized therapy.” Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: “[18F]fluoromethylcholine has been the current approved and established standard for PET/CT imaging of prostate cancer in Europe, and the publication of this manuscript validates our success in developing new diagnostic imaging solutions – as we continue on our journey to redefine the experience of cancer through our trusted legacy in nuclear medicine.” In the U.S., piflufolastat (18F) was approved by the Food and Drug Administration (FDA) in May 2021 and is commercially available as PYLARIFY® and sold by Lantheus. The PYTHON publication in European Journal of Nuclear Medicine and Molecular Imaging can be found here. PYTHON Study The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety proﬁles of [18F]DCFPyL and [18F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent. This study successfully met the primary endpoint. About PYLARIFY® (piflufolastat F 18, also known as [18F]DCFPyL) Injection PYLARIFY® (piflufolastat F 18) injection (also known as [18F]DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.1-6 PYLARIFY is FDA-approved and commercialized in the U.S. by Lantheus. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2019. About CuriumCurium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com For more information:Ross BethellVP, Head of Global Communicationscommunications@curiumpharma.com 1Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.20201916892Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.3Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.4Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.5Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-02906PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

Phase 3Drug ApprovalClinical ResultRadiation Therapy

100 Deals associated with 18F-Fluoromethylcholine

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	Canada	The Jewish General Hospital	01 Sep 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2023	Not Applicable	Prostatic Cancer	-	18F-FluorocholineRadium 223 dichloride (18F-Fluorocholine PET/CT)	(hijpvllmsx) = median OS of 16 months oobnqebtut (xvrdemgghp ) View more	-	28 Aug 2023
SNMMI2023	Not Applicable	Prostatic Cancer	-	223Ra therapy		-	28 Aug 2023
EANM2022	Not Applicable	Thyroid Cancer, Medullary calcitonin \| CEA levels	-	18F-Fluorocholine (Neck-US)	spjjbpuvtm(bsuchnynhr) = bdovfhupik jvzstqhogf (qjsipalbtx ) View more	-	22 Sep 2022
EANM2022	Not Applicable	Recurrent Prostate Carcinoma	-	18F-DCFPyL	hcpfisasvz(pfvwlsszkr) = fngeiyvpjt fcdamfiblr (fuoobxufnd ) View more	-	22 Sep 2022
EANM2022	Not Applicable	Recurrent Prostate Carcinoma	-	18F-Fluorocholine	hcpfisasvz(pfvwlsszkr) = oxsezlyrth fcdamfiblr (fuoobxufnd ) View more	-	22 Sep 2022
NCT03764007 (CTgov)	Phase 2/3	Hyperparathyroidism, Primary \| Parathyroid Adenoma	98	Positron Emission Tomography (PET)+18F-Fluorocholine	uomkxsgpgh(vhgrcmjpig) = piyjhptirs hhgengjfcn (ikrsduwqpm, clfxtimwvz - hcqypfuewz) View more	-	19 Oct 2021
EANM2021	Not Applicable	Recurrent Prostate Carcinoma	-	18F-fluorocholine (FCH-PET/CT + SBRT)	(fvbxfjbzqr) = ufudhwgmnm jdwguupnbq (rpxdrsnyjm, 4.13 - 13.9)	Negative	24 Sep 2021
EANM2021	Not Applicable	Hyperparathyroidism, Primary	35	¹⁸F-Fluoromethylcholine (Neck USG)	(jweiawtewr) = txqrncmeqt zjesowjspj (lcfqlhgpop ) View more	Positive	24 Sep 2021
EANM2021	Not Applicable	Hyperparathyroidism, Primary	35	¹⁸F-Fluoromethylcholine (99mTc-MIBI)	(jweiawtewr) = qaeweshhik zjesowjspj (lcfqlhgpop ) View more	Positive	24 Sep 2021
EANM2021	Not Applicable	Castration-Resistant Prostatic Cancer \| Bone metastases	48	radium-22318F-fluorocholine (Bone scintigraphy + 18F-fluorocholine PET/CT)	(rxgsfkbvmg) = mmxrrglied grshnlzgho (xnbpznjcuj )	-	24 Sep 2021
EANM2021	Not Applicable	Recurrent Prostate Carcinoma	68	18F-Fluciclovine PET/CT	vqcxdjbfol(cirarkphuw) = mephgdyrnb pgijoaxtvu (ixwbmaodqh )	Positive	24 Sep 2021
EANM2021	Not Applicable	Recurrent Prostate Carcinoma	68	18F-Fluorocholine18F-Fluciclovine (18F-Fluorocholine PET/CT)	vqcxdjbfol(cirarkphuw) = rletlwygjl pgijoaxtvu (ixwbmaodqh )	Positive	24 Sep 2021
SNMMI2021	Not Applicable	Parathyroid Adenoma	-	18F-fluorocholine (Sestamibi imaging)	qjjhcryuht(khijxgozph) = hcxulrdfkq tdvffmyoan (xhmxeqjhtc, 0.10 - 0.27)	-	18 May 2021
NCT01395030 (CTgov)	Phase 2	Hepatocellular Carcinoma	64	Computed Tomography+18F-fluoromethylcholine	asffgrtjty(xciydtdevg) = omsbdettsv aheimcxxhf (lmmltwansi, gjigiayhta - frkvkofmle) View more	-	26 Sep 2018

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