Breast CancerNCT03400215
Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
A study testing Diagnostic Breast Cancer Scan and Research Scan for Gradient-echo Spectroscopic Imaging (GSI) in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic Breast Cancer Scan and Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Diagnostic Breast Cancer Scan, Research Scan for Gradient-echo Spectroscopic Imaging (GSI)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Breast Cancer ScanDiagnostic test
clinically indicated diagnostic breast MRI scans
Research Scan for Gradient-echo Spectroscopic Imaging (GSI)Diagnostic test
Also called Gradient-echo Spectroscopic Imaging
15-min research MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer confirmed by biopsy | Active comparator | Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy Receives: Diagnostic Test: Diagnostic Breast Cancer Scan; Diagnostic 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. Receives: Diagnostic Test: Diagnostic Breast Cancer Scan; Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start23 Jul 2018
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Moy, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400215
- Sponsor's protocol ID
- 17-01549
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2018
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gradient-Echo Spectroscopic Imaging Study of Saturated Fat and Breast Cancer
- ClinicalTrials.gov ID
- NCT03400215
- Acronym / sponsor ID
- 17-01549
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer confirmed by biopsy | Active comparator | Diagnostic Test: Diagnostic Breast Cancer Scan, Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)Cases will be women first diagnosed with invasive breast cancer confirmed by biopsy |
| Women without any history of breast cancer | Active comparator | Diagnostic Test: Diagnostic Breast Cancer Scan, Diagnostic Test: Research Scan for Gradient-echo Spectroscopic Imaging (GSI)No known malignancy confirmed by at least 1-year follow up exams. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Breast Cancer Scanclinically indicated diagnostic breast MRI scans | Diagnostic test | Breast cancer confirmed by biopsy, Women without any history of breast cancer |
| Research Scan for Gradient-echo Spectroscopic Imaging (GSI)Also: Gradient-echo Spectroscopic Imaging15-min research MRI scan | Diagnostic test | Breast cancer confirmed by biopsy, Women without any history of breast cancer |
Primary outcome
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions.
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Moy, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Breast Cancer Scan and Research Scan for Gradient-echo Spectroscopic Imaging (GSI) in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare GSI-measured breast SFA fraction between women with malignant and benign lesions. (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.