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Diagnostic Test
GSI Breast Scan for Breast Cancer
N/A
Recruiting
Led By Linda Moy, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)
No contraindication to gadolinium contrast agent (severe renal insufficiency (EGFR<30), allergy to gadolinium) which will be injected for clinical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial found that the percentage of saturated fat in breast adipose tissue is higher in postmenopausal women with aggressive breast cancer than in those with only benign lesions.
Who is the study for?
This trial is for postmenopausal women over 25 without MRI contraindications (like pacemakers or severe obesity), no severe kidney issues, no allergies to gadolinium contrast, and who haven't had breast surgery or implants in the last year. Hormonal therapy recipients are excluded.Check my eligibility
What is being tested?
The study tests a new rapid MRI method called Gradient-echo Spectroscopic Imaging (GSI) that maps saturated and unsaturated fats in breast tissue, potentially linking fat composition to breast cancer development without needing a biopsy.See study design
What are the potential side effects?
There may be side effects from the MRI contrast agent used, such as allergic reactions or discomfort at the injection site. The GSI scan itself is non-invasive with minimal risks similar to standard MRIs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can safely undergo an MRI scan.
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I don't have severe kidney issues or allergies to gadolinium.
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I am a woman over 25 and have gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.
Trial Design
2Treatment groups
Active Control
Group I: Breast cancer confirmed by biopsyActive Control2 Interventions
Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy
Group II: Women without any history of breast cancerActive Control2 Interventions
No known malignancy confirmed by at least 1-year follow up exams.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,374 Previous Clinical Trials
840,622 Total Patients Enrolled
37 Trials studying Breast Cancer
7,133 Patients Enrolled for Breast Cancer
Linda Moy, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
1 Trials studying Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on hormonal therapy.I can safely undergo an MRI scan.I don't have severe kidney issues or allergies to gadolinium.I am a woman over 25 and have gone through menopause.I cannot have an MRI due to a pacemaker, metal implant, weight over 135 kg, or kidney issues.I had breast surgery or got breast implants in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Breast cancer confirmed by biopsy
- Group 2: Women without any history of breast cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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