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

This study is currently recruiting participants.
Verified May 2017 by Case Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02055586
First Posted: February 5, 2014
Last Update Posted: May 10, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  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 Device: positron emission tomography Device: magnetic resonance imaging

Study Type: Interventional
Study Design: 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

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 ]
    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 ]
    Describe changes in images at baseline PET/MRI scan compared to PET/MRI image taken after initiation of anti-angiogenic therapy


Estimated Enrollment: 20
Actual Study Start Date: October 22, 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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
Device: positron emission tomography
Undergo FLT-PET/MRI
Other Names:
  • PET/MR
  • PET
  • PET scan
  • tomography, emission computed
Device: magnetic resonance imaging
Undergo FLT-PET/MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
04-13-13C
CASE 3Y12 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: February 3, 2014
First Posted: February 5, 2014
Last Update Posted: May 10, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No