Identification of Novel Natural Substrates of Fibroblast Activation Protein-alpha by Differential Degradomics and Proteomics.
Hui Emma Zhang, Elizabeth J Hamson, Maria Magdalena Koczorowska...
https://pubmed.ncbi.nlm.nih.gov/30257879Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID07215182
[68Ga]Ga-FAPI PET/CT for Response Evaluation During Immune Checkpoint Inhibitor Therapy in Malignant Melanoma
Led by Barbara Malene Fischer · Updated on 2025-10-10
20
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
B
Barbara Malene Fischer
Lead Sponsor
H
Herlev Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the tracer [68Ga]Ga-FAPI-46 in PET/CT imaging to better assess how patients with advanced stage malignant melanoma respond to immune checkpoint inhibitor therapy (ICT). The study's main goal is to determine if this new imaging method can improve response evaluation compared to the standard [18F]FDG PET/CT and possibly act as a biomarker for treatment effectiveness. Participants with advanced malignant melanoma will undergo two PET/CT scans using the experimental tracer [68Ga]Ga-FAPI-46: one before starting ICT treatment and another after three months. These scans are additional to their standard imaging. Blood samples will also be collected twice, and patients will receive standard ICT treatment as prescribed by their medical team. During the study, participants will have their scans and blood samples analyzed to observe changes in tracer uptake in both cancerous lesions and healthy tissues. Researchers will follow up passively for six months after the last PET/CT scan to monitor outcomes. The primary outcome measured is the change in [68Ga]Ga-FAPI-46 uptake in malignant lesions over a three-month period, with further monitoring extending to nine months total from enrollment.
CONDITIONS
Brief Title
[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years or older
- Histologically verified metastatic or locally advanced malignant melanoma
- Visible malignant lesions on [18F]FDG PET/CT or CT
- Considered inoperable
- Medically suitable for immune checkpoint inhibitor therapy
- Able to read and understand patient information in Danish to give informed consent
You will not qualify if you...
- Diagnosis of ocular or mucosal melanoma
- Presence of other concurrent cancer diseases
- Previous systemic oncological treatment with immune checkpoint inhibitors
- Pregnancy or lactation
- Weight exceeding 140 kg (maximum PET/CT scanner bed limit)
- History of allergic reaction to compounds similar to [68Ga]Ga-FAPI-46
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 3 months
Participants undergo two PET/CT scans with the experimental tracer [68Ga]Ga-FAPI-46 to evaluate response during immune checkpoint inhibitor therapy.
2 visits for PET/CT scans
Long-term Monitoring
Duration - Approximately 6 months following the second PET/CT scan
Participants are monitored for changes in tracer uptake in healthy tissue after the scans to assess long-term effects.
Follow-up visits as determined by the study team
Trial Site Locations
Total: 2 locations
1
Herlev Universityhospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
2
Rigshospitalet
Copenhagen, Ca, Denmark, 2100
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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Published Research Related To This Trial
Equivalent tumor detection for early and late FAPI-46 PET acquisition.
J Ferdinandus, L Kessler, N Hirmas...
https://pubmed.ncbi.nlm.nih.gov/33620560Fibroblast-Activation Protein PET and Histopathology in a Single-Center Database of 324 Patients and 21 Tumor Entities.
Nader Hirmas, Rainer Hamacher, Miriam Sraieb...
https://pubmed.ncbi.nlm.nih.gov/36581374Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 PET Imaging in Cancer Patients.
Catherine Meyer, Magnus Dahlbom, Thomas Lindner...
https://pubmed.ncbi.nlm.nih.gov/31836685Early Detection of Checkpoint Inhibitor-Associated Myocarditis Using 68Ga-FAPI PET/CT.
Daniel Finke, Markus B Heckmann, Esther Herpel...
https://pubmed.ncbi.nlm.nih.gov/3371844668Ga-FAPI-46 and 18F-FDG PET/CT in a patient with immune-related thyroiditis induced by immune checkpoint inhibitors.
Masatoshi Hotta, Ida Sonni, Matthias R Benz...
https://pubmed.ncbi.nlm.nih.gov/33914106PET/CT Imaging of Activated Cancer-Associated Fibroblasts Predict Response to PD-1 Blockade in Gastric Cancer Patients.
Xiaoxiang Rong, Jinyu Lv, Yantan Liu...
https://pubmed.ncbi.nlm.nih.gov/35155199The Dark Side of Fibroblasts: Cancer-Associated Fibroblasts as Mediators of Immunosuppression in the Tumor Microenvironment.
Lea Monteran, Neta Erez
https://pubmed.ncbi.nlm.nih.gov/31428105[68 Ga]Ga-FAPI versus [18F]F-FDG in malignant melanoma: complementary or counterpoint?
Kgomotso Mokoala, Novruzov Emil, Ismaheel Lawal...
https://pubmed.ncbi.nlm.nih.gov/35137262Perspective of Targeting Cancer-Associated Fibroblasts in Melanoma.
Linli Zhou, Kun Yang, Thomas Andl...
https://pubmed.ncbi.nlm.nih.gov/26185533