9. What IBs will QuIC-ConCePT qualify?
Imaging Biomarkers (IBs) of tumor cell proliferation using 3′-deoxy-3′-[18F] fluorothymidine (FLT) positron emission tomography (PET).
IBs of tumor cell death using magnetic resonance imaging (MRI) apparent self-diffusion coefficient (ADC) of water protons.
IBs of tumor cell apoptosis using caspase PET tracer [18F]ICMT-11.
Exploratory objective to devise, evaluate, and introduce IBs of invasion and metastasis.
FLT  and ADC  are already widely used; but are:
- mainly single-center;
- sometimes difficult in important anatomic sites (lung, liver);
- clinical study design and interpretation difficult – particularly when imaging biomarker is negative (which timepoint, which analysis?).
 42 oncology trials enrolling 1922 patients using FLT as a biomarker in clinicaltrials.gov (33/42 non-neuro).
 75 oncology trials enrolling 6071 patients using ADC as a biomarker in clinicaltrials.gov (53/75 non-neuro).