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

Phase 2RecruitingNCT07215182

Barbara Malene Fischer20 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Malignant Melanoma Stage IV

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Herlev Universityhospital

Herlev, Capital Region, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Ca, Denmark

RECRUITING

Outcomes

Primary Outcomes

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.

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 Outcomes

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

Tracer-uptake in healthy tissue and benign lesions on \[68Ga\]Ga-FAPI-46 PET/CT will be evaluated using the same method as described in "Primary Objectives". A similar evaluation of standard \[18F\]FDG PET/CT will be performed. FAPI-uptake in healthy tissue on \[68Ga\]Ga-FAPI-46 PET/CT will be compared to the findings on \[18F\]FDG PET/CT. To verify the \[68Ga\]Ga-FAPI-46 PET/CT assessment (including evaluation of healthy tissue, malignant lesions and benign lesions), the assessment will be compared to the findings from a composed reference standard. This consist of all available imaging, biopsy results, blood tests, and information on hospitalization and changes in patient management up to 6 months after the \[68Ga\]Ga-FAPI PET/CT.

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).