This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer \[18F\]AlF-RESCA-IL2 in patients prior to and during treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1
Patients will undergo \[18F\]AlF-RESCA-IL2 PET imaging twice; the first \[18F\]AlF-RESCA-IL2 PET scan will be performed at baseline, before starting therapy. The second \[18F\]AlF-RESCA-IL2 PET scan will be performed after 2 weeks of treatment
University Medical Center Groningen
Groningen, Netherlands
Incidence of adverse events related to [18F]-AlF-RESCA-IL2 administration as assessed by CTCAE v5.0
Safety assessment through summaries of adverse events, changes in laboratory test results (if evaluation is indicated) and changes in vital signs. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0
Time frame: 2 years
Non-displaceable binding potential (BPND)
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Time frame: 2 years
Total volume of distribution (VT) of the tracer in the tumour
To evaluate the pharmacokinetic behaviour of 18F-AIF-RESCA-IL2 through activity in venous blood samples, dynamic imaging, and pharmacokinetic modeling.
Time frame: 2 years
Biodistribution of [18F]-AlF-RESCA-IL2
Evaluation of \[18F\]AlF-RESCA-IL2 biodistribution in cancer patients on the PET images by measuring standardized uptake values in tumours, healthy tissues and organs.
Time frame: 2 years
Correlation of 18F-AlF-RESCA-IL2 uptake in tumours, with T cell infiltration in tumour biopsy samples, as determined by IHC.
Results of immunohistochemical (IHC) scoring of immune cell IL-2R expression will be described as a semi-quantitative score using the percentage of positive cells (continuous variable), intensity and pattern of staining (discrete variable). These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Time frame: 2 years
Correlation of 18F-AlF-RESCA-IL2 PET measurements with radiologic response to treatment, according to (i)RECIST v1.1 criteria.
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Response to therapy will be assessed according to the RECIST or iRECIST guidelines. These results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images.
Time frame: 2 years
Assessment of changes in tumour and normal organ tracer uptake after 2 weeks of treatment, expressed as standardized uptake values.
Patients will undergo a PET scan at baseline and another one during treatment. tracer uptake will be quantified and expressed as standardized uptake value (SUV) in defined volumes of interest (VOIs) for both scans. The results of both PET scans will be compared to assess changes in imaging tracer uptake over time.
Time frame: 2 years