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Recruiting NCT07215182

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

Phase II Interventional Malignant Melanoma Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-FAPI-46.
Who it may be relevant to
Registry conditions: Malignant Melanoma Stage IV. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

[68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma

Overview

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

Interventions

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

Primary outcome measures

  • Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT [Time frame: From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months.]
Secondary outcome measures (1)
  • Changes in [68Ga]Ga-FAPI-46-uptake during ICT in healthy tissue [Time frame: 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).]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Denmark · 2 centers
  • Herlev Universityhospital — Herlev
  • Rigshospitalet — Copenhagen

Publications

  • 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
  • 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
  • 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 o PMID 36581374
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07215182 · 522_22 · 2023-509549-11-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗