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

A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents

This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT)-positron emission tomography/magnetic resonance imaging (PET/MRI) in measuring early response in patients with metastatic solid tumors receiving treatment that blocks blood flow to the tumor. Diagnostic procedures, such as FLT-PET/MRI, may help measure a patient's response earlier during treatment.

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 (SOC) 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)