[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer

NCT07215182 | Recruiting Phase 2 DMC

• 2 other identifiers: 522_222023-509549-11-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Malignant Melanoma Stage IV

Keywords

FAPI PET/CT; Immune checkpoint inhibitor therapy; malignant melanoma; response evaluation

Outcome Measures

Primary Outcomes (1)

• Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT

  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.

  From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.

Secondary Outcomes (1)

• Changes in [68Ga]Ga-FAPI-46-uptake during ICT in healthy tissue

  From enrollment in the study (signed informed consent) to the end of the follow-up (6 months after the second [68Ga]Ga-FAPI-46 PET/CT, estimated time in total is 9 months from signed informed consent).

Other Outcomes (1)

• Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP-activity biomarkers in serum blood samples during ICT.

  From enrollment in the study (signed informed consent) to the end of the follow-up (6 months after the second [68Ga]Ga-FAPI-46 PET/CT, estimated time in total is 9 months from signed informed consent).

Study Arms (1)

Advanced staged Malignant Melanoma

EXPERIMENTAL

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.

Drug: [68Ga]Ga-FAPI-46

Interventions

[68Ga]Ga-FAPI-46 DRUG

Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).

Advanced staged Malignant Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, \>/=18 years old
• Histological verified metastatic or locally advanced malignant melanoma
• Visible malignant lesions on \[18F\]FDG PET/CT or CT
• Subjects must be considered inoperable
• Subjects must be considered medically suitable for ICT
• Subjects must be able to read and understand the patient information in Danish to give informed consent

You may not qualify if:

• Ocular or mucosal melanoma
• Other concurrent cancer disease
• Previous systemic oncological treatment with ICT
• Pregnancy or lactation
• Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
• History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI- 46

Sponsors & Collaborators

• Barbara Malene Fischer: lead
• Herlev Hospital: collaborator

Study Sites (2)

Herlev Universityhospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Ca, 2100, Denmark

RECRUITING

Related Publications (11)

• 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.

  PMID: 30257879 BACKGROUND

• 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.

  PMID: 33620560 BACKGROUND

• 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.

  PMID: 36581374 BACKGROUND

• 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.

  PMID: 31836685 BACKGROUND

• 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.

  PMID: 33718446 BACKGROUND

• 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.

  PMID: 33914106 BACKGROUND

• 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.

  PMID: 35155199 BACKGROUND

• 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.

  PMID: 31428105 BACKGROUND

• 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.

  PMID: 35137262 BACKGROUND

• 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.

  PMID: 26185533 BACKGROUND

• 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.

  PMID: 30734283 BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: The baseline and the follow-up \[68Ga\]Ga-FAPI-46 PET/CT scan will be evaluated by a team of experienced specialists in clinical physiology and nuclear medicine, and radiology. These specialists are blinded from findings on the standard imaging (\[18F\]FDG PET/CT).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Ph.D.

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 10, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

DK (2)