GSI Breast Scan for Breast Cancer

Overseen By Samuel Brazil

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Hormonal therapy

Disqualifiers: Breast surgery, Breast implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the role of breast fat in breast cancer development. Researchers use a new MRI technique called the Diagnostic Breast Cancer Scan to measure fat types in breast tissue without surgery. The study compares two groups: women diagnosed with breast cancer and those without any history of it. Postmenopausal women with a confirmed breast cancer diagnosis by biopsy or no history of breast cancer may qualify. Participants should not have conditions that prevent MRI scans or allergies to the contrast agent used in the procedure. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could lead to new insights into breast cancer prevention and diagnosis.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on any hormonal therapy, you cannot participate in the trial.

What prior data suggests that the GSI Breast Scan is safe for use in breast cancer diagnosis?

Research has shown that Gradient-echo Spectroscopic Imaging (GSI), a new MRI technique, can safely measure different types of fat in breast tissue. This non-invasive method does not involve surgery or tissue sampling. Studies have demonstrated that GSI can create detailed images of various fats in the breast without causing harm.

As a scanning technique, not a drug or surgical procedure, GSI is generally easy for people to tolerate. No reports have linked negative effects directly to this imaging method. It is designed to be quick and safe, reducing the need for more invasive tests.

This trial is in the "Not Applicable" phase, focusing on whether this method can aid in diagnosing breast cancer, rather than testing a new drug. The safety information is based on using this imaging technique, which is considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GSI Breast Scan because it offers a potentially more accurate and less invasive way to detect breast cancer compared to traditional mammograms or ultrasounds. Unlike these standard imaging techniques, which can sometimes miss small tumors or provide false positives, the GSI Breast Scan uses advanced imaging technology to provide clearer and more detailed images of breast tissue. This could lead to earlier and more accurate diagnosis, which is crucial for effective treatment. Additionally, by potentially reducing the need for unnecessary biopsies, this scan can make the diagnostic process less stressful and invasive for patients.

What evidence suggests that the GSI Breast Scan is effective for breast cancer detection?

Research has shown that the type of fat in the breast may play a role in the development of breast cancer. One small study found that postmenopausal women with aggressive breast cancer had more saturated fat in their breast tissue compared to those with non-cancerous lumps. This finding suggests a possible link between the type of fat and cancer risk. In this trial, researchers will use a new MRI method, Gradient-echo Spectroscopic Imaging (GSI), to identify different types of fat in the breast without needing a tissue sample. This technique could help detect cancer risk early by revealing differences in breast tissue fat. Participants will include women with breast cancer confirmed by biopsy and women without any history of breast cancer. ^{1 5 6 7 8}

Who Is on the Research Team?

Linda Moy, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able and willing to provide informed consent

I can safely undergo an MRI scan.

I don't have severe kidney issues or allergies to gadolinium.

Exclusion Criteria

I am currently on hormonal therapy.

I cannot have an MRI due to a pacemaker, metal implant, weight over 135 kg, or kidney issues.

I had breast surgery or got breast implants in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo diagnostic breast MRI exams using Gradient-echo Spectroscopic Imaging (GSI) to measure fatty acid composition

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in breast adipose tissue composition and potential development of breast cancer

1 year

Regular follow-up exams

What Are the Treatments Tested in This Trial?

Interventions

• Diagnostic Breast Cancer Scan
• Research Scan for Gradient-echo Spectroscopic Imaging (GSI)

Trial Overview 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.

How Is the Trial Designed?

Group I: Breast cancer confirmed by biopsy Active Control 2 Interventions

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

Group II: Women without any history of breast cancer Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

MRI techniques, particularly T1- and T2-weighted sequences, were successfully adapted for examining canine mammary glands in a study involving 10 dogs, providing detailed imaging for diagnosing tumors.

The MRI results closely correlated with histological findings, indicating that these imaging methods can effectively differentiate between benign and malignant tumors, aiding in staging and prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging technique for the examination of canine mammary tumours. Garamvölgyi, R., Petrási, Z., Hevesi, A., et al.[2006]

In a study of 5343 women undergoing screening MR imaging for breast cancer, the cancer detection rate (CDR) was 17 per 1000 examinations, which is slightly below the BI-RADS benchmark of 20-30 per 1000, indicating room for improvement in detection rates.

The screening MR imaging demonstrated a sensitivity of 81% and specificity of 83%, both of which are close to the BI-RADS benchmarks, suggesting that while the performance is generally good, there are still areas that could be enhanced for better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance Benchmarks for Screening Breast MR Imaging in Community Practice. Lee, JM., Ichikawa, L., Valencia, E., et al.[2018]

High spectral and spatial resolution (HiSS) echo-planar spectroscopic imaging (EPSI) significantly improved the visibility and detail of suspicious breast lesions in 30 women, even before the administration of contrast agents.

HiSS images provided better lesion conspicuity and margin definition compared to standard clinical images, suggesting that this technique could enhance the diagnostic accuracy of breast MRI by allowing characterization of lesions based on high-resolution spectral information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High spectral and spatial resolution MRI of breast lesions: preliminary clinical experience. Medved, M., Newstead, GM., Abe, H., et al.[2008]

Abbreviated and ultrafast breast MRI techniques are being integrated into clinical practice to improve breast cancer screening by reducing interval cancers and enhancing diagnostic accuracy while minimizing overdiagnosis.

These MRI techniques may allow for noninvasive tumor subtyping, which could lead to more personalized breast cancer management and treatment strategies, as they provide insights into tumor characteristics that traditional methods may miss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abbreviated and Ultrafast Breast MRI in Clinical Practice. Gao, Y., Heller, SL.[2021]

In a study of 67 patients with 92 suspicious breast lesions, semi-quantitative breast-specific gamma imaging (BSGI) demonstrated a high sensitivity of 90% for detecting malignancies, second only to ultrasound, which had a sensitivity of 99%.

BSGI showed the highest specificity (56%), positive-predictive value (85%), and accuracy (80%) compared to other imaging methods, suggesting that a negative BSGI result could potentially eliminate the need for biopsy in lesions over 1 cm with low to moderate risk of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Added value of semi-quantitative breast-specific gamma imaging in the work-up of suspicious breast lesions compared to mammography, ultrasound and 3-T MRI. Meissnitzer, T., Seymer, A., Keinrath, P., et al.[2018]

Early diagnosis and accurate treatment of breast cancer can lead to a cure in 90% of cases, highlighting the critical role of diagnostic imaging in improving disease outcomes.

Recent advancements in imaging techniques, such as MRI and PET-CT, enhance the detection and characterization of breast cancer, although none can provide a definitive histological diagnosis without imaging-guided biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of imaging in the diagnostic and therapeutic algorithms of breast cancer]. Godény, M., Szabó, E., Bidlek, M., et al.[2016]

In a study of 45 breast cancer patients and 35 benign tumor patients, key MRI indicators for diagnosing breast cancer were identified, including tumor edge features, time-signal intensity curve (TIC) types, and apparent diffusion coefficient (ADC) values at b=500 s/mm2.

The combination of conventional MRI, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced MRI provided the best diagnostic approach, with magnetic resonance spectroscopy (MRS) serving as a useful supplementary tool for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. Jiang, Z., Wang, Y., He, Z., et al.[2015]

Magnetic resonance imaging (MRI) is more sensitive than x-ray mammography for detecting breast cancer, making it a crucial tool for early detection and monitoring treatment responses.

Magnetic resonance spectroscopy (MRS) provides valuable biochemical information about tumor metabolism, which can aid in cancer staging and assessing how well treatments are working.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance in the detection of breast cancers of different histological types. Mayrhofer, RM., Ng, HP., Putti, TC., et al.[2021]

The accelerated 5D EP-COSI technique successfully identified novel biomarkers in breast cancer, including glycine, myo-inositol, and unsaturated fatty acids, which can help differentiate between healthy, benign, and malignant tissues.

Metabolite and lipid ratio maps generated from this technique showed significant potential as complementary markers of malignancy, enhancing the diagnostic capabilities for breast cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlated MR spectroscopic imaging of breast cancer to investigate metabolites and lipids: acceleration and compressed sensing reconstruction. Joy, A., Saucedo, A., Joines, M., et al.[2023]

In a study of 231 newly diagnosed breast cancer patients, the analysis of breast-specific gamma imaging (BSGI) uptake features revealed that irregular shapes in mass uptake were significantly associated with malignancy, indicating a potential marker for cancer detection.

For non-mass uptake, a linear or ductal distribution pattern was more predictive of malignancy compared to other distribution types, suggesting that specific characteristics of BSGI uptake can help differentiate between benign and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of feature analysis of breast-specific gamma imaging for predicting malignancy. Choi, EK., Im, JJ., Park, CS., et al.[2020]

Magnetic Resonance (MR) imaging is emerging as a highly accurate method for detecting breast implant failures and may become an essential tool for breast imaging, similar to breast ultrasound today.

While MR imaging shows great promise for detecting both invasive and noninvasive breast cancer that conventional methods might miss, its specificity is limited, and further large-scale clinical trials are needed to validate its effectiveness and establish guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging of the breast. Orel, SG.[2019]

A noninvasive multimodal sono-contrast induced spectroscopy (SCIS) system was tested on 66 subjects, showing a high accuracy in distinguishing between breast cancer and benign masses, achieving an area under the curve (AUC) of 0.93.

The system demonstrated a sensitivity of 96.0% and specificity of 84.1%, indicating it is highly effective in correctly identifying cancerous tissues while minimizing false positives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical study of a noninvasive multimodal sono-contrast induced spectroscopy system for breast cancer diagnosis. Yan, K., Yu, Y., Tinney, E., et al.[2021]

Breast-specific gamma imaging (BSGI) demonstrated a high positive predictive value of 92.9% in detecting additional or more extensive malignancies in newly diagnosed breast cancer patients, identifying such cases in 10.9% of patients.

With a low false-positive rate of 7.2%, BSGI offers a reliable imaging option that reduces unnecessary follow-ups, improving clinical management and decision-making for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of breast-specific gamma imaging for evaluating disease extent in the newly diagnosed breast cancer patient. Zhou, M., Johnson, N., Gruner, S., et al.[2016]

MRI screening for high-risk women can significantly increase the detection of breast cancers, particularly identifying cancers before they spread to lymph nodes.

While MRI offers benefits in cancer detection, it also carries risks of false positives, which may result in unnecessary additional imaging or benign biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening MRI for women at high risk for breast cancer. Lehman, CD.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03400215

Gradient-Echo Spectroscopic Imaging Study of Saturated ... The proposed study will evaluate whether breast saturated fat is an independent risk factor for breast cancer, and whether it can provide additional diagnostic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12213879/

Advances in breast cancer diagnosis: a comprehensive ... Early diagnosis significantly improves prognosis and long-term survival rates. Various techniques, including imaging, sensors, and molecular biotechnology, have ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8178936/

Magnetic Resonance Imaging in Screening of Breast Cancer Although mammography screening has been highly effective in early cancer detection in average-risk women more than 40 years of age, interval cancers persist at ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/14/9/e069788

Meta-analysis and systematic review of the diagnostic ... Conclusions The CESM has high sensitivity and good specificity when it comes to evaluating breast cancer, particularly in women with dense breasts. Thus, ...

5. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.232580

Diagnostic Accuracy of Screening Contrast-enhanced ... Overall, the cancer detection rate of LE imaging was 4.0 per 1000 screenings, which increased to 12.7 per 1000 screenings for CEM. Based on ...

6. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10322559&term=CA219964

Division of Cancer Control & Population Sciences - Grant Details Recently, we have developed a rapid MRI method, referred to as Gradient-echo Spectroscopic Imaging (GSI), to measure fatty acid composition during clinical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6568320/

Fatty acid composition in mammary adipose tissue measured ... Fatty acid composition of mammary adipose tissue, particularly higher SFA and lower MUFA, may be associated with breast cancer.

8. clinicaltrial.be clinicaltrial.be/en/details/69717?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Gradient-Echo Spectroscopic Imaging Study of Saturated ... The proposed study will evaluate whether breast saturated fat is an independent risk factor for breast cancer, and whether it can provide ...