Clinical trial · Interventional
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
[68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma
NCT07215182CI-TRIAL-00096468BEFASTrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to investigate the use of the tracer \[68Ga\]Ga-FAPI-46 for PET/CT-imaging in response evaluation of patients with advanced stage malignant melanoma treated with immune checkpoint inhibitor therapy (ICT). The main question it aims to answer is: • Can \[68Ga\]Ga-FAPI-46 PET/CT improve response evaluation in patients suffering from advanced stage malignant melanoma treated with ICT and potentially serve as a biomarker. Researchers will compare findings on the experimental \[68Ga\]Ga-FAPI-46 PET/CT with findings on standard imaging (\[18F\]FDG PET/CT). Participants will undergo: * Two \[68Ga\]Ga-FAPI-46 PET/CT scans: one before treatment initiation with ICT and one after three months. * Two blood samples * Passive follow-up 6 months after the last scan \[68Ga\]Ga-FAPI-46 PET/CT
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-FAPI-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Advanced staged Malignant Melanoma
- description
- Patients with advanced stage malignant melanoma with visible lesions on \[18F\]FDG PET/CT referred for ICT at the Dept. of Oncology Herlev Hospital will be sought enrolled. Patients will undergo two \[68Ga\]Ga-FAPI-46 PET/CT, which include injection with the experimental tracer \[68Ga\]Ga-FAPI-46. These scans are in addition to their standard imaging.
- interventionNames
- Drug: [68Ga]Ga-FAPI-46
Primary outcomes (1)
- measure
- Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT
- timeFrame
- From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.
- description
- Specified malignant lesions will be defined and evaluated by a team of specialists on the baseline \[68Ga\]Ga- FAPI PET/CT scan and the uptake of the FAPI tracer in the lesions will be quantified. The evaluation of the malignant lesions on \[68Ga\]Ga-FAPI PET/CT will also be compared with a similar lesion evaluation on the \[18F\]FDG PET/CT (standard imaging). The FAPI-uptake will be reassessed after 12 weeks of ICT by the same team of specialists. Changes in uptake of malignant lesions after 12 weeks of ICT on the \[68Ga\]Ga-FAPI-46 PET/CT will be compared to changes on the \[18F\]FDG PET/CT and the clinical response. The clinical response will be assessed using the patients' medical record.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, \>/=18 years old 2. Histological verified metastatic or locally advanced malignant melanoma 3. Visible malignant lesions on \[18F\]FDG PET/CT or CT 4. Subjects must be considered inoperable 5. Subjects must be considered medically suitable for ICT 6. Subjects must be able to read and understand the patient information in Danish to give informed consent Exclusion Criteria: 1. Ocular or mucosal melanoma 2. Other concurrent cancer disease 3. Previous systemic oncological treatment with ICT 4. Pregnancy or lactation 5. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg) 6. History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46
References
Publications (11)
- BACKGROUNDZhang HE, Hamson EJ, Koczorowska MM, Tholen S, Chowdhury S, Bailey CG, Lay AJ, Twigg SM, Lee Q, Roediger B, Biniossek ML, O'Rourke MB, McCaughan GW, Keane FM, Schilling O, Gorrell MD. Identification of Novel Natural Substrates of Fibroblast Activation Protein-alpha by Differential Degradomics and Proteomics. Mol Cell Proteomics. 2019 Jan;18(1):65-85. doi: 10.1074/mcp.RA118.001046. Epub 2018 Sep 26. PMID 30257879
- BACKGROUNDFerdinandus J, Kessler L, Hirmas N, Trajkovic-Arsic M, Hamacher R, Umutlu L, Nader M, Zarrad F, Weber M, Fendler WP. Equivalent tumor detection for early and late FAPI-46 PET acquisition. Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3221-3227. doi: 10.1007/s00259-021-05266-7. Epub 2021 Feb 23. PMID 33620560
- BACKGROUNDHirmas N, Hamacher R, Sraieb M, Ingenwerth M, Kessler L, Pabst KM, Barbato F, Lueckerath K, Kasper S, Nader M, Schildhaus HU, Kesch C, von Tresckow B, Hanoun C, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Niedergethmann M, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Fibroblast-Activation Protein PET and Histopathology in a Single-Center Database of 324 Patients and 21 Tumor Entities. J Nucl Med. 2023 May;64(5):711-716. doi: 10.2967/jnumed.122.264689. Epub 2022 Dec 29. PMID 36581374
- BACKGROUNDMeyer C, Dahlbom M, Lindner T, Vauclin S, Mona C, Slavik R, Czernin J, Haberkorn U, Calais J. Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 PET Imaging in Cancer Patients. J Nucl Med. 2020 Aug;61(8):1171-1177. doi: 10.2967/jnumed.119.236786. Epub 2019 Dec 13. PMID 31836685
- BACKGROUNDFinke D, Heckmann MB, Herpel E, Katus HA, Haberkorn U, Leuschner F, Lehmann LH. Early Detection of Checkpoint Inhibitor-Associated Myocarditis Using 68Ga-FAPI PET/CT. Front Cardiovasc Med. 2021 Feb 25;8:614997. doi: 10.3389/fcvm.2021.614997. eCollection 2021. PMID 33718446
- BACKGROUNDHotta M, Sonni I, Benz MR, Gafita A, Bahri S, Shuch BM, Yu R, Liu ST, Czernin J, Calais J. 68Ga-FAPI-46 and 18F-FDG PET/CT in a patient with immune-related thyroiditis induced by immune checkpoint inhibitors. Eur J Nucl Med Mol Imaging. 2021 Oct;48(11):3736-3737. doi: 10.1007/s00259-021-05373-5. Epub 2021 Apr 29. No abstract available.