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

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• Triple Negative Breast Neoplasms 1,140

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's enrollment of 96 is above the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Study arms

• Experimental
  Diagnostic (DCE-MRI, MBI)

  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

• ProcedureDynamic Contrast-Enhanced Magnetic Resonance Imaging

  Undergo DCE-MRI

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

• OtherLaboratory Biomarker Analysis

  Correlative studies

• RadiationScintimammography

  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

• DrugTechnetium Tc-99m Sestamibi

  Given via injection

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

Primary outcomes

1. 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.

   Time frame: Up to 4 years

2. 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.

   Time frame: up to 6 months

3. 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).

   Time frame: 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

   Assessed by baseline SUVb and baseline genomic signature. Will fit one logistic regression model with baseline SUVb and baseline genomic signature as covariates and response to the upfront chemotherapy as the endpoint and one model with baseline DCE-MRI tumor volume and baseline genomic signature as covariates and response to the upfront chemotherapy as the endpoint. Will assess the predictive accuracy of this model by estimating the area under the ROC curve using the predicting response probability and the observed response outcome. ROC curves will be generated for each modality and each TNBC molecular subtype and compute the areas under these curves along with 95% confidence intervals. Will determine a cut-point in the predicted probabilities to classify patients as predicted responders and non-responders based an appropriate trade-off between sensitivity and specificity.

   Time frame: up to 6 months

Related links

• University of Texas MD Anderson Cancer Center Website ↗