DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer

NCT02744053 | Active Not Recruiting Early Phase 1 FDA Drug

• 3 other identifiers: 2015-0816NCI-2016-00715P30CA016672
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Percent change in volume of index tumors and estimated area under receiver operating characteristic (ROC) curves assessed by digital mammogram, ultrasound, dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and molecular breast imaging (MBI)

  The ability to assess and predict response will be compared among the imaging modalities and with standard pathological evaluation. These volume changes will be correlated with residual cancer burden (RCB) status after surgery and will be used to classify patients into predicted responder or non-responder categories. Predictive accuracies among the imaging modalities will be compared using paired ROC curve analyses.

  Up to 4 years

• Percent change in tumor volume assessed by dynamic Tc99m-sestamibi MBI

  The index tumor will be measured on both cranial-caudal (CC) and medio-lateral oblique (MLO) views and 3 dimension will be recorded. The percentage change in volume at time points 2 and 3 relative to baseline imaging (time point 1) will be calculated. Data acquisition and image processing algorithms will be developed from having conjugate views of the breast in the MBI examination. Appropriate methods to correct the image from loss of contrast due to scatter and loss of signal from photon attenuation as it transits breast tissue will be explored and implemented. Will investigate the correlations of absolute and relative values of baseline standardized uptake value (SUVb) with pathological tumor response.

  up to 6 months

• Tumor response assessed by pathological examination

  Correlations of pathological response with absolute and relative values of MBI SUVb will be investigated. The longest dimension of the residual tumor will be measured. If only foci of disease are seen the longest dimension of tumor cell distribution will be measured. The M D Anderson Cancer Center (MDACC) Residual Cancer Burden Calculator will be used to categorize cancer burden: RCB-0 (no residual disease in breast or in lymph nodes), RCB-1 (minimal residual disease), RCB-2 (moderate residual disease), or RCB-3 (extensive residual disease).

  Up to 4 years

Other Outcomes (1)

• Utility of molecular breast imaging (MBI) and dynamic contrast enhanced molecular resonance imaging (DCE-MRI) together with molecular profiling to identify a subgroup of chemoresistant triple negative breast cancer (TNBC) patients

  up to 6 months

Study Arms (1)

Diagnostic (DCE-MRI, MBI)

EXPERIMENTAL

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).

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Laboratory Biomarker Analysis; Radiation: Scintimammography; Drug: Technetium Tc-99m Sestamibi

Interventions

Dynamic Contrast-Enhanced Magnetic Resonance Imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Diagnostic (DCE-MRI, MBI)

Technetium Tc-99m Sestamibi DRUG

Given via injection

Also known as: Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi

Diagnostic (DCE-MRI, MBI)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (DCE-MRI, MBI)

Scintimammography RADIATION

Undergo MBI

Also known as: Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test, Molecular Breast Imaging, Nuclear Medicine Breast Imaging, sestamibi breast imaging, Sestamibi Scintimammography

Diagnostic (DCE-MRI, MBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has proven TNBC, defined by standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (\< 10% tumor staining) and negative for human epidermal growth factor 2 (HER2) (immunohistochemistry \[IHC\] score \< 3, gene copy number not amplified)
• TNBC patients who are previously untreated and enrolled in the prospective Institutional Review Board (IRB) approved clinical trial: 2014-0185
• Patients who are able to understand and give consent to participating in the study

You may not qualify if:

• Is pregnant (confirmed by the patient as imaging clinic standard of care) or nursing mother
• Has lesions involving chest wall
• Has known allergy to Tc99m sestamibi
• Has known contraindications to MRI
• Has contraindication to MRI contrast

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson in Katy

Houston, Texas, 77094, United States

Location

MD Anderson League City

Nassau Bay, Texas, 77058, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

MD Anderson in The Woodlands

The Woodlands, Texas, 77384, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Study Officials

• Gaiane M Rauch

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 20, 2016
• Study Start: November 7, 2016
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (6)