An interventional study of IL2-PET scan and Tumor biopsy in Melanoma, sponsored by University Medical Center Groningen. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic
T cell infiltration of tumor lesions is a known prognostic factor in several tumor types and is used as treatment mechanism in some of these tumor types. In metastatic melanoma, treatment with immune checkpoint inhibitors induces clinical benefit in about 30-50% of the patients. These immune-based therapies are however accompanied by serious immune-related adverse events and high costs.
Tumor infiltrating T cells express the high affinity interleukin-2 (IL2) receptor on their surface. These T cells could therefore be visualized by molecular imaging with a radio-labelled ligand for this receptor. For this purpose, the investigators have developed the PET tracer [18F]FB-IL2.
The study commences with a biodistribution study (phase 1) in 5 subjects. Thereafter the main study (phase 2) starts, in which 25 subjects will receive two [18F]FB-IL2 PET scans at baseline and week 6 of treatment with either ipilimumab, nivolumab, pembrolizumab or the combination of ipilimumab and nivolumab. If [18F]FB-IL2 PET is able to detect a response to treatment, it could serve as a non-invasive early indicator of T cell response to the treatment. Besides, accumulation of the PET tracer in non-target tissue could indicate infiltration of activated T cells in normal organs and thus may predict the development of an immune-related adverse event.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 19 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Exclusion Criteria:
A history or evidence of cardiovascular risk including any of the following:
\[18F\]FB-IL2 PET scan, Tumor biopsy, CT scan, Biopsy of non-target tissue
Device: IL2-PET scan · Procedure: Tumor biopsy · Device: CT scan · Procedure: Biopsy of non-target tissue
All patients in this study will undergo a IL2 PET scan at baseline and week 6 of treatment with immunotherapy.
Also known as: [18F]FB-IL2 PET scan
A procedure to acquire tissue of a predetermined melanoma metastasis will be performed in all patients that participate in phase 2 of this study.
A CT scan of diagnostic quality will accompany all the PET scans and will additionally been made 12 and 16 weeks after start of immunotherapy to evaluate response to treatment.
A biopsy of skin and colon non-target tissue involved in an immune-related side effect is optional in patients that participate in phase 2 of this study.
Biodistribution and kinetics of [18F]FB-IL2.
Biodistribution and kinetics will be assessed in the first five patients that participate in this trial (phase 1). A 60-minute dynamic PET scan of the chest and 2 total-body PET scans at 60 and 120 minutes will be acquired to determine tracer kinetics and residence time of the tracer in major organs.
Time frame: 2 hours
The ability of the [18F]FB-IL2 PET to detect a treatment-induced immune response in tumors.
For detection of a treatment-induced immune response the absolute tracer uptake in tumor lesions will be compared between the scan at baseline and the scan after 6 weeks of treatment with ipilimumab, nivolumab, pembrolizumab or the combination of ipilimumab and nivolumab.
Time frame: 6 weeks
Correlation between tumor uptake of [18F]FB-IL2 with the number of IL2 receptor positive immune cells.
The amount of IL2 receptor positive cells will be scored by immunohistochemical staining of tumor biopsy material and will be correlated to the tumor uptake of \[18F\]FB-IL2.
Time frame: 2 days
Correlation between tumor uptake of [18F]FB-IL2 with response to therapy.
The increase in tumor uptake of \[18F\]FB-IL2 ofu the tumor lesions on the PET scan at baseline and week 6 of treatment with immunotherapy, will be correlated to radiological response as measured on the CT scans at week 6, 12 and 16 according to the RECIST 1.1 criteria.
Time frame: 16 weeks
To analyze heterogeneity in immune response to treatment between separate lesions, as determined by [18F]FB-IL2 PET.
Both the heterogeneity between separate lesions in one patient and between lesions in different patients will be determined and if possible will be correlated to treatment response (lesion based).
Time frame: 16 weeks
Treatment induced immune cell activation in non-target tissues and if possible the correlation of PET observations with side effects related to the tissue involved.
Treatment induced immune cell activation in non-target tissue will be determined by visually comparing the PET results at baseline and after 6 weeks of treatment. In regions with a higher tracer uptake on the week 6 scan the absolute uptake will be determined and this will be correlated to the development of an immune-related adverse event. In case of immune-related side effects localized to the skin or colon, biopsy samples are optional and tissue infiltration of IL2 receptor positive cells can be correlated to \[18F\]FB-IL2 uptake on PET.
Time frame: 16 weeks
Adverse events of [18F]FB-IL2 PET.
Adverse events will be recorded. Vital signs and blood parameters will be determined before and after tracer injection and directly after the PET scan for safety reasons.
Time frame: 16 weeks
Plan to share: No
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen