This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using \[99mTc\]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).
A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
15
Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITINGPD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT
To measure PD-L1 expression in NSCLC (primary tumour and metastatic lesions) as assessed using \[99mTc\]-NM-01 SPECT/CT and compare to PD-L1 expression determined by IHC.
Time frame: Day 0
Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions
To assess the safety of \[99mTc\]-NM-01 SPECT/CT scan by observing for Adverse Drug Reactions (ADRs) occurring during the trial.
Time frame: Up to 12 days post-injection
PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion
To measure intra-tumoural heterogeneity in the primary tumour, as well as in individual metastases and inter-tumoural heterogeneity between different disease sites (including different metastatic sites and between primary tumour and its metastases).
Time frame: Day 0
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