Imaging Techniques for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two imaging techniques to predict responses to chemotherapy in patients with triple negative breast cancer (TNBC). The methods under study are dynamic contrast-enhanced MRI (a detailed scan) and technetium-Tc99m sestamibi molecular breast imaging (MBI, a special imaging using a tracer). These scans might help doctors determine which patients will benefit most from their treatment. The trial seeks participants diagnosed with TNBC who have not yet started treatment. As an Early Phase 1 trial, this research focuses on understanding how these imaging techniques work in people, offering participants a chance to contribute to groundbreaking advancements in cancer 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.

What prior data suggests that these imaging techniques are safe for assessing tumor response in breast cancer patients?

Previous studies have shown that DCE-MRI is a safe and noninvasive method for diagnosing breast cancer. It accurately detects cancer without harming the patient. Research indicates that technetium Tc-99m sestamibi imaging carries a very low risk of side effects. This imaging agent is often used for heart scans due to its high tolerance among patients.

Overall, both imaging methods have been used safely in medical settings. DCE-MRI and technetium Tc-99m sestamibi enable doctors to assess breast cancer response to treatment without surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging techniques for breast cancer because they offer a more detailed view of how the cancer is responding to treatment. Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) provides a dynamic picture of blood flow in tumors, which can highlight changes not easily visible with standard imaging like mammograms or ultrasounds. Meanwhile, Molecular Breast Imaging (MBI) using technetium Tc-99m sestamibi offers metabolic insights, showing how active the cancer cells are based on their uptake of the tracer. These advanced imaging methods could help tailor treatments more precisely and quickly assess whether a therapy is working.

What evidence suggests that these imaging techniques are effective for assessing tumor response in triple negative breast cancer?

In this trial, participants will undergo both Dynamic Contrast-Enhanced MRI (DCE-MRI) and Technetium Tc-99m Sestamibi imaging. Research has shown that DCE-MRI effectively detects cancer by revealing changes in tiny blood vessels. Studies have found that delayed-phase DCE-MRI is particularly useful for assessing the size of remaining tumors after chemotherapy. Technetium Tc-99m Sestamibi reliably diagnoses breast cancer, especially when other tests are inconclusive. It accurately identifies breast cancer and helps predict tumor response to treatment. Both imaging methods show promise for evaluating chemotherapy effectiveness in patients with triple-negative breast cancer (TNBC). ^{5 6 7 8 9}

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

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4202481/

Review of treatment assessment using DCE-MRI in breast ... DCE-MRI is a promising technique for assessing breast cancer radiation treatment due to its inherent sensitivity to the microvascular environment changes.

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.2018172868

Dynamic Contrast-enhanced Breast MRI for Evaluating ... Delayed-phase MRI is more accurate than early-phase MRI for evaluating residual breast tumor size after neoadjuvant chemotherapy.

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1403262/full

Analysis of dynamic contrast-enhanced T1-weighted ... This study suggests that the DCE-T1WI parameters are different in benign and malignant breast lesions with type II DCE TIC. Tp was independently ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X24000287

Contrast-enhanced breast imaging: Current status and ... Contrast-enhanced breast imaging using breast MRI is the most powerful breast cancer screening method and offers superior cancer detection regardless of breast ...

5. nature.com nature.com/articles/s41598-023-48553-z

Lesion detection in women breast's dynamic contrast- ... The results showed that mammography combined with CAD provided 100% sensitivity for malignancies presenting as microcalcifications and 86% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8636198/

Diagnostic performance of dynamic contrast‐enhanced ... DCE-MRI is a noninvasive method of breast cancer diagnosis for suspected malignant breast lesions with relative high diagnostic sensitivity and specificity.

7. nature.com nature.com/articles/s41523-021-00247-3

Dynamic contrast-enhanced breast MRI features correlate ... Our study suggests DCE-MRI can non-invasively assess breast cancer angiogenesis, which could stratify biology and optimize treatments.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/18654999/

Dynamic contrast-enhanced MRI in the diagnosis and ... Dynamic contrast-enhanced MRI (DCE-MRI) is an evolving tool for determining breast disease, which benefits from the move to imaging at 3 T.

9. cancerimagingarchive.net cancerimagingarchive.net/collection/qin-breast-dce-mri/

QIN-BREAST-DCE-MRI - The Cancer Imaging Archive (TCIA) This collection of breast dynamic contrast-enhanced (DCE) MRI data contains images from a longitudinal study to assess breast cancer response to neoadjuvant ...