Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT03400215
Collaborator
(none)
170
1
2
78.1
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic Breast Cancer Scan
  • Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
N/A

Detailed Description

The overarching goal of this study is to determine the role of saturated fatty acid in breast cancer development and growth. In this proposal, GSI will be used for non-invasive in vivo measurement of saturated fat in the breast adipose tissue of postmenopausal women who undergo diagnostic breast MRI exams (Aims 1 and 2) or MRI-guided biopsy scans (Aim 3). The central hypotheses is that (i) the breast saturated fatty acid fraction measured by GSI is associated with the presence of malignant lesions in the breast and (ii) the breast saturated fatty acid fraction correlates positively with inflammation in the breast adipose tissue that may lead to increase in estrogen production in adipocytes.The proposed study will evaluate whether breast saturated fat is an independent risk factor for breast cancer, and whether it can provide additional diagnostic information to current clinical diagnostic exams. In addition, the proposed imaging measure of breast saturated fat can be used to assess the efficacy of any intervention to reduce cancer-related inflammation in the breast adipose tissue and to investigate the possible role of fatty acid composition in prevention and clinical management of breast cancer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
Actual Study Start Date :
Jul 23, 2018
Anticipated Primary Completion Date :
Jul 26, 2022
Anticipated Study Completion Date :
Jan 23, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Breast cancer confirmed by biopsy

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

Diagnostic Test: Diagnostic Breast Cancer Scan
clinically indicated diagnostic breast MRI scans

Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
15-min research MRI scan
Other Names:
  • Gradient-echo Spectroscopic Imaging
  • Active Comparator: Women without any history of breast cancer

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

    Diagnostic Test: Diagnostic Breast Cancer Scan
    clinically indicated diagnostic breast MRI scans

    Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
    15-min research MRI scan
    Other Names:
  • Gradient-echo Spectroscopic Imaging
  • Outcome Measures

    Primary Outcome Measures

    1. To compare GSI-measured breast SFA fraction between women with malignant and benign lesions. [5 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Health New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health

    Investigators

    • Principal Investigator: Linda Moy, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03400215
    Other Study ID Numbers:
    • 17-01549
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021