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

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Device: magnetic resonance imaging

Other: fluorine F 18 fluorothymidine

Device: positron emission tomography

Study type

Observational

Funder types

Other

Identifiers

NCT02055586

NCI-2013-01177 (Registry Identifier)

CASE3Y12

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)