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

Barbara Malene Fischer

Status and phase: Enrolling; Phase 2

Conditions: Malignant Melanoma Stage IV

Treatments: Drug: [68Ga]Ga-FAPI-46

Study type: Interventional

Funder types: Other

Identifiers

NCT07215182

2023-509549-11-00 (EU Trial (CTIS) Number)

522_22

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, >/=18 years old
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

1. Ocular or mucosal melanoma
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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Advanced staged Malignant Melanoma

Experimental group

Description:

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.

Treatment:

Drug: [68Ga]Ga-FAPI-46