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

Trial Summary

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 data supports the idea that GSI Breast Scan for Breast Cancer is an effective treatment?

The available research shows that MRI, which is similar to GSI, is very sensitive in detecting both invasive and noninvasive breast cancer. MRI can find cancers that are not visible with other methods like mammography or ultrasound, making it a promising tool for early detection and treatment planning. However, the research also indicates that MRI is still in the investigational stage and needs more large-scale studies to confirm its effectiveness. While MRI is not the same as GSI, the similarities suggest that GSI could also be effective in detecting breast cancer early, which is crucial for successful treatment. ^{1 2 3 4 5}

What safety data exists for the GSI Breast Scan for Breast Cancer?

The provided research does not contain specific safety data for the GSI Breast Scan or its related names. The studies focus on breast-specific gamma imaging (BSGI) and MRI, discussing their diagnostic value, performance benchmarks, and clinical utility, but do not address safety data for GSI or its variants. ^{1 6 7 8 9}

Is the GSI Breast Scan a promising treatment for breast cancer?

Yes, the GSI Breast Scan is a promising treatment for breast cancer because it offers a noninvasive way to detect breast cancer with improved accuracy and detail. It uses advanced imaging techniques to identify cancerous tissues and can help in early diagnosis, which is crucial for effective treatment. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Linda Moy, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

MR imaging of the breast. [2019]

3. Hungary pubmed.ncbi.nlm.nih.gov

[Role of imaging in the diagnostic and therapeutic algorithms of breast cancer]. [2016]

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[Optimization of diagnosis indicator selection and inspection plan by 3.0T MRI in breast cancer]. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance in the detection of breast cancers of different histological types. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Performance Benchmarks for Screening Breast MR Imaging in Community Practice. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical utility of breast-specific gamma imaging for evaluating disease extent in the newly diagnosed breast cancer patient. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Usefulness of feature analysis of breast-specific gamma imaging for predicting malignancy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical study of a noninvasive multimodal sono-contrast induced spectroscopy system for breast cancer diagnosis. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Correlated MR spectroscopic imaging of breast cancer to investigate metabolites and lipids: acceleration and compressed sensing reconstruction. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

High spectral and spatial resolution MRI of breast lesions: preliminary clinical experience. [2008]

13. United States pubmed.ncbi.nlm.nih.gov

Abbreviated and Ultrafast Breast MRI in Clinical Practice. [2021]

14. Hungary pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging technique for the examination of canine mammary tumours. [2006]