Imaging Techniques for Breast Cancer

Recruiting at 5 trial locations

Overseen By Gaiane M. Rauch, MD, PHD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Nursing, Chest wall lesions, others

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

Compensation: Varies

Number of Visits: 3

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI may help researchers predict which patients may respond to treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Dynamic Contrast-Enhanced MRI safe for humans?

The research indicates that contrast-enhanced MRI is used safely in breast cancer imaging to stage disease, assess treatment response, and screen high-risk patients, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the imaging treatment for breast cancer differ from other treatments?

This imaging treatment uses Tc-99 m sestamibi, a radioactive tracer, to create functional images of the breast, which can help assess the response to chemotherapy or evaluate breast cancer risk. Unlike traditional imaging methods, it provides detailed information about the biological activity of breast tissue, potentially improving diagnostic accuracy and personalizing treatment plans. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Y-90 SIRT, Selective Internal Radiation Therapy, Radioembolization, Technetium Tc-99m Sestamibi for breast cancer?

The research highlights that magnetic resonance imaging (MRI) is highly sensitive in detecting breast cancer and assessing tumor response to treatment, which can help tailor treatment plans. MRI's ability to visualize small tumor deposits and assess local tumor burden can aid in selecting appropriate therapies and potentially avoid unnecessary treatments. ^{11 12 13 14 15}

Who Is on the Research Team?

Gaiane M. Rauch

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who can consent to participate, have confirmed triple negative breast cancer (TNBC) with no prior treatment, and are enrolled in the clinical trial: 2014-0185. It's not for those with MRI contraindications, pregnant or nursing women, patients with chest wall-involved lesions, allergies to Tc99m sestamibi, or issues with MRI contrast.

Inclusion Criteria

My breast cancer is triple-negative, not showing positive for estrogen, progesterone, or HER2.

I have triple-negative breast cancer and haven't started treatment yet.

I understand the study and agree to participate.

Exclusion Criteria

Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother

You are allergic to Tc99m sestamibi.

You cannot have an MRI with contrast dye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Chemotherapy

Participants undergo DCE-MRI and MBI scans at enrollment, end of anthracycline therapy, and conclusion of NAC before surgery. Standard of care imaging with DM and US may also be performed.

Up to 6 months

3 imaging sessions

Follow-up

Participants are monitored for tumor response and safety after chemotherapy, with assessments up to 4 years.

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
• Technetium Tc-99m Sestamibi

Trial Overview The study is testing how well DCE-MRI and MBI imaging techniques measure the effectiveness of chemotherapy in TNBC patients. These advanced scans might help predict patient response to treatment before it's visible through standard methods.

How Is the Trial Designed?

Group I: Diagnostic (DCE-MRI, MBI) Experimental Treatment 4 Interventions

Patients undergo DCE-MRI over 45-60 minutes. Patients receive technetium Tc-99m sestamibi via injection, and after 5 minutes patients undergo MBI scan over 1 hour. Both DCE-MRI and MBI are performed at the time of enrollment, at the end of anthracycline therapy, and at the conclusion of NAC before surgery. All patients also undergo standard of care imaging with DM and US (at the same time points if the treating doctor chooses to do so).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

MRI screening for women at high familial risk of breast cancer is approximately twice as sensitive as X-ray mammography, allowing for earlier detection of smaller, node-negative lesions.

The findings from the UK MARIBS study and other comparative studies have led to updated screening recommendations for high-risk women, emphasizing the importance of MRI in their screening protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer screening in women at high risk using MRI. Leach, MO.[2009]

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]

Citations

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

Breast magnetic resonance imaging alters patient selection for accelerated partial breast irradiation. [2018]

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

Feasibility of abbreviated magnetic resonance imaging (AB-MRI) screening in women with a personal history (PH) of breast cancer. [2020]

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

Magnetic resonance imaging for screening, diagnosis, and eligibility for breast-conserving surgery: promises and pitfalls. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative radiotherapy omission in selected patients with early breast cancer following preoperative breast MRI (PROSPECT): primary results of a prospective two-arm study. [2023]

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

MR imaging for assessment of breast cancer response to neoadjuvant chemotherapy. [2007]

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

Sensitivity of Contrast-Enhanced Breast MRI vs X-ray Mammography Based on Cancer Histology, Tumor Grading, Receptor Status, and Molecular Subtype: A Supplemental Analysis of 2 Large Phase III Studies. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Breast cancer screening in women at high risk using MRI. [2009]

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

Contrast media in breast imaging. [2015]

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

Magnetic resonance imaging identifies multifocal and multicentric disease in breast cancer patients who are eligible for partial breast irradiation. [2008]

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

Tumor Response After Neoadjuvant Magnetic Resonance Guided Single Ablative Dose Partial Breast Irradiation. [2020]

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

Comparison of technetium-99m-sestamibi scintimammography with contrast-enhanced MRI for diagnosis of breast lesions. [2016]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of Tc-99 m sestamibi uptake quantification with few-projection emission tomography. [2023]

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

MRI phenotype of breast cancer: Kinetic assessment for molecular subtypes. [2015]

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

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

15. England pubmed.ncbi.nlm.nih.gov

Comparison of 99mTc-sestamibi scintimammography and dynamic MR imaging as adjuncts to mammography in the diagnosis of breast cancer. [2019]