NCT03400215

Brief Summary

The role of fat in breast cancer development and growth has been studied extensively using body mass index, a measure of whole body fatness, and dietary fat intake in a number of epidemiological studies. However, there is a paucity of studies, on an individual level, to assess the role of breast fat itself in breast cancer due to lack of a non-invasive and fast measurement method. Since breast fibroglandular cells are surrounded by breast fat cells, the characteristics of breast fat may have a stronger relationship with breast cancer development, as supported by recent studies showing that a majority of breast cancer develops at the interface between fibroglandular tissue and adipose tissue. However, it is not trivial to study the role of breast fat, mainly due to the lack of a non-invasive and fast measurement method sensitive enough to important features of breast fat, such as types of fat.Recently, we have developed a rapid MRI method, referred to as Gradient-echo Spectroscopic Imaging (GSI), to measure fatty acid composition during clinical breast MRI exams. GSI can provide map of saturated fat and unsaturated fats in the breast adipose tissue without performing tissue biopsy. Our pilot study found that the postmenopausal women with aggressive breast cancer, known as invasive ductal carcinoma, have a significantly higher percentage of saturated fat in their breast adipose tissue than the postmenopausal women with only benign lesions.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7.7 years

First QC Date

January 9, 2018

Last Update Submit

February 10, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.

    5 Years

Study Arms (2)

Breast cancer confirmed by biopsy

ACTIVE COMPARATOR

Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy

Diagnostic Test: Diagnostic Breast Cancer ScanDiagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)

Women without any history of breast cancer

ACTIVE COMPARATOR

No known malignancy confirmed by at least 1-year follow up exams.

Diagnostic Test: Diagnostic Breast Cancer ScanDiagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)

Interventions

Research Scan for Gradient-echo Spectroscopic Imaging (GSI)DIAGNOSTIC_TEST

15-min research MRI scan

Also known as: Gradient-echo Spectroscopic Imaging
Breast cancer confirmed by biopsyWomen without any history of breast cancer
Diagnostic Breast Cancer ScanDIAGNOSTIC_TEST

clinically indicated diagnostic breast MRI scans

Breast cancer confirmed by biopsyWomen without any history of breast cancer

Eligibility Criteria

Age25 Years - 99 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Able and willing to provide informed consent
  • Post-menopausal age \> 25 years.

You may not qualify if:

  • Contra-indication to MRI or gadolinium contrast agent (have a pacemaker, aneurysm clip, or other metallic implant; weigh \>135 kg; or have renal impairment)
  • Breast surgery within prior 12 months, or breast implants
  • Any hormonal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Linda Moy, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

July 23, 2018

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(1)