FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents

PRIMARY OBJECTIVES:

The primary objective of this pilot imaging study is to determine the feasibility of
FLTPET/MR imaging for early prediction of treatment response in patients undergoing
antiangiogenic cancer treatment. The study will assess PET/MRI test-retest reproducibility
and compare baseline PET/MRI with PET/MRI after initiation (within 2-4 weeks) of
antiangiogenic therapy.

SECONDARY OBJECTIVES:

- To compare early changes in PET biomarker (FLT) tumor uptake with treatment response
assessed at completion of therapy (prediction of treatment response).

- To compare changes in MRI signal intensities (multi-parametric MRI) with treatment
response assessed at completion of therapy.

- To compare results from multi-parametric MR imaging with FLT tumor uptake.

- To assess combinations of quantitative PET and MRI metrics.

OUTLINE:

Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of
treatment.

Inclusion Criteria:

- Patients with metastatic solid tumors scheduled to undergo treatment with novel cancer
therapeutic agents as standard of care treatment.

- Patients able to tolerate PET/MRI scans

- Informed consent must be given and signed

Exclusion Criteria:

- Subjects who do not meet the above mentioned inclusion criteria

- Subjects who refuse to give and/or sign the informed consent

- Patients who currently have a pacemaker

- Patients who have a history of serious adverse events related to a previous MRI or
PET/CT

- Patients who are unable to undergo MRI scanning due to exclusion by UHCMC MRI
restriction policies as mentioned in the standard UHCMC MRI informed consent form

- Patients with a known allergy against any component of the contrast enhancing agent

- Patients who currently pregnant or breast feeding; negative serum pregnancy test
within 72 hours of their first FLT-PET/MRI

- Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 4 weeks

- Renal insufficiency: elevated creatinine and/or glomerular filtration rate (GFR) < 40
ml/min/1.73^2 (exclusion criterion only for contrast enhanced MRI)