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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02055586
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 23, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Other: fluorine F 18 fluorothymidine Device: positron emission tomography Device: magnetic resonance imaging Not Applicable

Detailed Description:


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.


  • 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of FLT-PET/MRI for Early Response Monitoring to Novel Cancer Therapeutic Agents
Actual Study Start Date : October 22, 2013
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : December 27, 2017

Arm Intervention/treatment
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

Device: positron emission tomography
Other Names:
  • PET/MR
  • PET
  • PET scan
  • tomography, emission computed

Device: magnetic resonance imaging
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Primary Outcome Measures :
  1. Concordance analysis of standardized uptake values (SUVs) between the 2 baseline scans [ Time Frame: Baseline ]
    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.

  2. Comparative Analysis of PET/MRI Images [ Time Frame: Up to 4 weeks ]
    Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02055586

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

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Responsible Party: Case Comprehensive Cancer Center Identifier: NCT02055586    
Other Study ID Numbers: CASE3Y12
NCI-2013-01177 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 3Y12 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cariostatic Agents
Protective Agents
Physiological Effects of Drugs