NCT02055586

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	fluorine F 18 fluorothymidine	Undergo FLT-PET/MRI
DEVICE	positron emission tomography	Undergo FLT-PET/MRI
DEVICE	magnetic resonance imaging	Undergo FLT-PET/MRI

Timeline

• Start date: 2013-10-22
• Primary completion: 2017-11-27
• Completion: 2017-12-27
• First posted: 2014-02-05
• Last updated: 2020-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study