FLT-PET / MRI in Measuring Early Response in Patients with Metastatic Solid Tumors Receiving Treatment That Blocks Blood Flow to the Tumor

Status: Temporarily Closed to Accrual

Description

This pilot clinical trial studies whether fluorine F 18 fluorothymidine (FLT) will enable positron emission tomography / magnetic resonance imaging (PET / MRI) to measure response earlier in patients with metastatic solid tumors who are receiving treatment with agents that reduce the growth of new blood vessels. Diagnostic procedures, such as FLT-PET / MRI, are used to measure a patient's response to earlier treatment.

Eligibility Criteria

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)

Locations & Contacts

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Contact: Norbert Avril
Phone: 216-286-3210
Email: Norbert.Avril@UHhospitals.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of FLT-PET/MR imaging for early prediction of treatment response in patients undergoing anti-angiogenic cancer treatment.

II. To assess the test-retest reproducibility of PET biomarker (FLT) uptake using PET/MRI.

III. To assess the test-retest reproducibility of quantification of MR sequences (multi-parametric MRI particularly related to tissue perfusion).

IV. To assess the ability of PET/MRI to measure changes in PET biomarker (FLT) tumor uptake after initiation of therapy.

V. To assess changes in qualitative morphologic imaging and quantitative functional MRI parameters after initiation of therapy.

SECONDARY OBJECTIVES:

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

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

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

IV. 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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Case Comprehensive Cancer Center

Principal Investigator
Norbert Avril

Trial IDs

Primary ID CASE 3Y12
Secondary IDs NCI-2013-01177
Clinicaltrials.gov ID NCT02055586