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Initial Assessment of 18FDG-PET/MRIin Determining the Extent of Systemic Disease in Breast Cancer Patients

This study is currently recruiting participants.
Verified March 2013 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01672021
First received: August 21, 2012
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

Because MRI can provide increased brain and liver lesion detection as compared with CT, the investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.


Condition Intervention
Breast Cancer
 Procedure: MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Number of metastatic lesions seen on PET/MRI as compared with PET/CT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient stage as imaged by PET/MRI as compared with PET/CT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET/MRI Procedure: MRI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance

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Exclusion Criteria:

  • Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672021

Contacts
Contact: Amy N Melsaether, MD amymelsaether@nyumc.org

Locations
United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Amy N Melsaether, MD            
Principal Investigator: Amy N Melsaether, MD            
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Amy Melsaether, MD NYU School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01672021     History of Changes
Other Study ID Numbers: S12-02243
Study First Received: August 21, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Breast Cancer
MRI PET-CT

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013