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

N/ACompletedNCT02055586

Case Comprehensive Cancer Center10 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

fluorine F 18 fluorothymidineOTHER

Undergo FLT-PET/MRI

positron emission tomographyDEVICE

Undergo FLT-PET/MRI

magnetic resonance imagingDEVICE

Undergo FLT-PET/MRI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans

A sample size of 20 produces a two-sided 95% confidence interval \[0.553, 0.918\] for the Pearson correlation coefficient when the sample correlation is 0.80. Additional analysis for concordance will include Bland-Altman plots and intraclass correlation.

Time frame: Baseline

Comparative Analysis of PET/MRI Images

Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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