Measurement of PD-L1 expression in cancer to monitor treatment response. A prospective non-blinded, single centre, single interventional arm diagnostic imaging study. To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using \[99mTc\]-anti-PD-L1 SPECT/CT and immunohistochemistry.
Using \[99mTc\]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITINGPercentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change. Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
Time frame: Up to 18 weeks
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change. Standard clinical imaging assessment at 12 and 24 weeks used as comparators.
Time frame: Up to 24 weeks
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.
Time frame: Baseline
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