[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
NCT ID: NCT07215182
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-08-15
2027-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Imaging FDG Flare in Melanoma
NCT02791594
Pilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma
NCT03356470
Vemurafenib and TIL Therapy for Metastatic Melanoma
NCT02354690
PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
NCT00004152
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
NCT04904120
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Advanced staged Malignant Melanoma
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.
[68Ga]Ga-FAPI-46
Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[68Ga]Ga-FAPI-46
Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Herlev Hospital
OTHER
Barbara Malene Fischer
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barbara Malene Fischer
Professor, MD, Ph.D.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Herlev Universityhospital
Herlev, Capital Region, Denmark
Rigshospitalet
Copenhagen, Ca, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Zhang 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.
Ferdinandus 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.
Hirmas 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.
Meyer 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.
Finke 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.
Hotta 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.
Rong X, Lv J, Liu Y, Wang Z, Zeng D, Li Y, Li S, Wu J, Shen Z, Shi M, Liao W, Wu Z, Wang C. PET/CT Imaging of Activated Cancer-Associated Fibroblasts Predict Response to PD-1 Blockade in Gastric Cancer Patients. Front Oncol. 2022 Jan 26;11:802257. doi: 10.3389/fonc.2021.802257. eCollection 2021.
Monteran L, Erez N. The Dark Side of Fibroblasts: Cancer-Associated Fibroblasts as Mediators of Immunosuppression in the Tumor Microenvironment. Front Immunol. 2019 Aug 2;10:1835. doi: 10.3389/fimmu.2019.01835. eCollection 2019.
Mokoala K, Emil N, Lawal I, Antke C, Giesel FL, Sathekge M. [68 Ga]Ga-FAPI versus [18F]F-FDG in malignant melanoma: complementary or counterpoint? Eur J Nucl Med Mol Imaging. 2022 Jun;49(7):2445-2446. doi: 10.1007/s00259-022-05702-2. Epub 2022 Feb 9. No abstract available.
Zhou L, Yang K, Andl T, Wickett RR, Zhang Y. Perspective of Targeting Cancer-Associated Fibroblasts in Melanoma. J Cancer. 2015 Jun 23;6(8):717-26. doi: 10.7150/jca.10865. eCollection 2015.
Nurmik M, Ullmann P, Rodriguez F, Haan S, Letellier E. In search of definitions: Cancer-associated fibroblasts and their markers. Int J Cancer. 2020 Feb 15;146(4):895-905. doi: 10.1002/ijc.32193. Epub 2019 Feb 28.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-509549-11-00
Identifier Type: CTIS
Identifier Source: secondary_id
522_22
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.