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

NCT07215182 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-10-10

No results posted yet for this study

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

Interventions

DRUG

[68Ga]Ga-FAPI-46

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

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Barbara Malene Fischer

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2026-08-20
Completion
2027-02-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215182 on ClinicalTrials.gov