A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Anti-Angiogenic Cancer Treatment

This study has suspended participant recruitment.
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National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
First received: February 3, 2014
Last updated: February 15, 2016
Last verified: February 2016
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: October 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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
Other Names:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorothymidine
  • fluorothymidine F-18
Procedure: positron emission tomography
Other Names:
  • PET/MR
  • PET
  • PET scan
  • tomography, emission computed
Procedure: magnetic resonance imaging
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Detailed Description:


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.


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.


Patients undergo FLT-PET/MRI twice at baseline and once within 4 weeks after start of treatment.


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

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

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Norbert Avril Case Comprehensive Cancer Center
  More Information

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: February 15, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2016