- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577915
Breast MRI Spectroscopy
The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease.
As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion
Exclusion Criteria:
Patients who would be normally excluded from undergoing an MRI examination:
- Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breast MR Spectroscopy
Conventional images will be taken with standard pulse sequences.
These images will be used for the diagnostic examination for which the patient will have been scheduled.
Following the diagnostic study, a pulse sequence designed to obtain spectroscopy data will be used.This will be used on the existing magnets 1.5T and 3T.
Memorial Sloan-Kettering Cancer Center has 1.5T and 3T magnets.
The patient will have only one injection of contrast (gadolinium-DTPA) for the initial diagnostic study.
No additional contrast will be administered.
The additional sequence should take about 10 minutes, depending on breast size.
|
MRI spectroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sandra Brennan, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suspicion of, or Known Breast Cancer
-
University of ArkansasUniversity of Arkansas, FayettevilleTerminatedKnown or Suspected Dysplasia or CancerUnited States
-
Anandasabapathy, Sharmila, M.D.Baylor College of Medicine; William Marsh Rice UniversityUnknownSuspected or Known Squamous Cell Neoplasia | Prior History of Squamous Cell Dysplasia and /or NeoplasiaUnited States, China
-
Anandasabapathy, Sharmila, M.D.Baylor College of Medicine; University of Sao Paulo; William Marsh Rice UniversityCompletedSuspected or Known Squamous Cell Neoplasia | Prior History of Squamous Cell Dysplasia and /or NeoplasiaUnited States, Brazil
-
IRCCS San RaffaeleRecruitingSuspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the ProstateItaly
-
Shandong Suncadia Medicine Co., Ltd.Enrolling by invitationMetastatic or Local Advanced Breast Cancer of PatientsChina
-
Sponsor GmbHGlaxoSmithKline; iOMEDICO AG; Arbeitsgemeinschaft fur Internistische Onkologie; Arbeitskreis Klinische StudienTerminatedMetastatic Breast Cancer | HER2 Positive | First or Second Line Therapy | Failure or Contraindication of Trastuzumab TherapyGermany
-
Nuvation Bio Inc.WithdrawnBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Breast Carcinoma | Cancer of Breast | Malignant Tumor of Breast | Breast Tumor | Cancer of the BreastUnited States
-
Kaiser PermanenteCompletedCancer of the Breast | Anomaly of BreastUnited States
-
Washington University School of MedicineNational Institute for Biomedical Imaging and Bioengineering (NIBIB)CompletedBreast Cancer | Breast Tumors | Cancer of Breast | Malignant Neoplasm of Breast | Cancer of the BreastUnited States
-
University of NebraskaBracco Diagnostics, Inc; Philips Medical SystemsCompletedHepatitis | Fibrosis of Liver | Underlying Liver Disease | Cirrhosis With Suspicion of Liver Cancer | Lesion on a Prior Ultrasound, CT or Outside MRIUnited States
Clinical Trials on Radiology/MRI scan
-
CHU de ReimsCompletedProximal Humerus Fracture | Reproducibility | Four Part Fracture | Hertel's CriteriaFrance
-
University of ChicagoRecruitingBreast CancerUnited States
-
Jeffrey A. Lieberman, MDTerminated
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)TerminatedSchizophreniaUnited States
-
The Clatterbridge Cancer Centre NHS Foundation...Unknown
-
University of LeicesterNational Institute for Health Research, United KingdomCompletedPatients With Heart Failure and Preserved Ejection Fraction - HFpEF | Patients With Heart Failure With Reduced Ejection Fraction - HFrEF | Healthy Controls Group - Age and Sex-matched
-
Radboud University Medical CenterCompletedHead and Neck NeoplasmsNetherlands
-
University Hospitals Bristol and Weston NHS Foundation...Bosum Buddies; Friends of the Bristol Haematology and Oncology CentreTerminated
-
M.D. Anderson Cancer CenterNot yet recruitingBrain Malignancies | PseudoprogressionUnited States
-
University College London HospitalsRecruitingArthritis, Juvenile Idiopathic | Enthesitis-Related Arthritis, JuvenileUnited Kingdom