Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic Breast Cancer Scan
Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Breast cancer confirmed by biopsy
Women without any history of breast cancer
Arm Description
Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy
No known malignancy confirmed by at least 1-year follow up exams.
Outcomes
Primary Outcome Measures
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03400215
Brief Title
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
Official Title
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
January 23, 2025 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer confirmed by biopsy
Arm Type
Active Comparator
Arm Description
Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy
Arm Title
Women without any history of breast cancer
Arm Type
Active Comparator
Arm Description
No known malignancy confirmed by at least 1-year follow up exams.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic Breast Cancer Scan
Intervention Description
clinically indicated diagnostic breast MRI scans
Intervention Type
Diagnostic Test
Intervention Name(s)
Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
Other Intervention Name(s)
Gradient-echo Spectroscopic Imaging
Intervention Description
15-min research MRI scan
Primary Outcome Measure Information:
Title
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.
Time Frame
5 Years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Sanger
Phone
6465010086
Email
Samantha.sanger@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Reshma Gadde
Email
Resma.Gadde@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Moy, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Fogarty
Phone
212-731-5318
Email
justin.fogarty@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Linda Moy, MD
12. IPD Sharing Statement
Learn more about this trial
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
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