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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02055586
First received: February 3, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Unspecified Adult Solid Tumor, Protocol Specific
Other: fluorine F 18 fluorothymidine
Procedure: positron emission tomography
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Anti-Angiogenic Cancer Treatment

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Comparative Analysis of PET/MRI Images [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy


Estimated Enrollment: 20
Study Start Date: July 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (FLT-PET/MRI)
Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.
Other: fluorine F 18 fluorothymidine
Undergo FLT-PET/MRI
Other Names:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorothymidine
  • fluorothymidine F-18
Procedure: positron emission tomography
Undergo FLT-PET/MRI
Other Names:
  • PET/MR
  • PET
  • PET scan
  • tomography, emission computed
Procedure: magnetic resonance imaging
Undergo FLT-PET/MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of FLT-PET/MRI 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic solid tumors scheduled to undergo University Hospitals (UH) Case Medical Center (UHCMC) standard of care anti-angiogenic therapy or treatment with biological agents known to inhibit angiogenesis
  • Patients able to tolerate PET/MRI scans
  • Informed consent must be given and signed

Exclusion 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055586

Locations
United States, Ohio
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Norbert Avril    216-286-3210    Norbert.Avril@UHhospitals.org   
Principal Investigator: Norbert Avril         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Norbert Avril Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02055586     History of Changes
Other Study ID Numbers: CASE3Y12, NCI-2013-01177, 04-13-13C, CASE 3Y12, P30CA043703
Study First Received: February 3, 2014
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on November 25, 2014