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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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
1,368 Previous Clinical Trials
839,592 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

Diagnostic Breast Cancer Scan (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT03400215 — N/A
Breast Cancer Research Study Groups: Breast cancer confirmed by biopsy, Women without any history of breast cancer
Breast Cancer Clinical Trial 2023: Diagnostic Breast Cancer Scan Highlights & Side Effects. Trial Name: NCT03400215 — N/A
Diagnostic Breast Cancer Scan (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03400215 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an estimation of the maximum quantity of participants in this trial?

"Affirmative. According to clinicaltrials.gov, the trial which opened on July 23rd 2018 is still recruiting candidates today. 170 patients are required for this study at a single location and it was last updated on September 8th 2022."

Answered by AI

Does this clinical trial extend to those younger than twenty years of age?

"This medical trial has a recruitment criteria that stipulates those interested must be between 25 and 99 years old."

Answered by AI

To whom is this clinical experiment open to enrollment?

"This clinical trial is searching for 170 individuals affected by breast cancer, aged between 25 and 99."

Answered by AI

Is registration still open for the experiment?

"Affirmative. It is evident from the clinicaltrials.gov webpage that this research trial has been recruiting participants since its inception on July 23rd 2018 and was recently refreshed on September 8th 2022. The study aims to enrol 170 individuals at a single facility."

Answered by AI
~15 spots leftby Jan 2025