[68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer
ConditionMalignant Melanoma Stage IV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Malene Fischer
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, >/=18 years old
Histological verified metastatic or locally advanced malignant melanoma
Visible malignant lesions on [18F]FDG PET/CT or CT
Subjects must be considered inoperable
Disqualifiers
Ocular or mucosal melanoma
Other concurrent cancer disease
Previous systemic oncological treatment with ICT
Pregnancy or lactation
Trial design
Design model
Single group
Treatments tested in this trial
[68Ga]Ga-FAPI-46
DrugPatients undergo two PET/CTs with the experimental tracer \[68Ga\]Ga-FAPI-46 (drug).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Advanced staged Malignant MelanomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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).Other outcomes
1
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.
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Barbara Malene Fischer
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Herlev Hospital
Collaborator
Source ClinicalTrials.gov