Malignant Melanoma Stage IV
Conditions
Keywords
FAPI PET/CT, Immune checkpoint inhibitor therapy, malignant melanoma, response evaluation
Brief 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
Interventions
DRUG[68Ga]Ga-FAPI-46
Patients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).
Sponsors
Herlev Hospital
Barbara Malene Fischer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The baseline and the follow-up \[68Ga\]Ga-FAPI-46 PET/CT scan will be evaluated by a team of experienced specialists in clinical physiology and nuclear medicine, and radiology. These specialists are blinded from findings on the standard imaging (\[18F\]FDG PET/CT).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in FAPI-uptake in malignant lesions on [68Ga]Ga-FAPI-46 PET/CT during ICT | From enrollment in the study (signed informed consent) to after the second [68Ga]Ga- FAPI PET/CT, estimated time is 3 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in [68Ga]Ga-FAPI-46-uptake during ICT in healthy tissue | 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). | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between [68Ga]Ga-FAPI-46-uptake on [68Ga]Ga-FAPI-46 PET/CT and levels of FAP-activity biomarkers in serum blood samples during ICT. | 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). | Blood samples from the included participants will be analyzed by Nordic Bioscience- Results from this analysis will be correlated to the disease activity evaluated on the \[68Ga\]Ga-FAPI-46 PET/CT. Results from the serum blood sample analysis will also be correlated with treatment outcome after 6 months of treatment. Treatment outcome will be defined using the RECIST criteria (40). This analysis will be done retrospectively on routine clinical scans (\[18F\]FDGPET/CT). The updated guideline and definitions of the RECIST criteria will be used. |
Countries
Denmark
Outcome results
None listed