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NCT Number: NCT02744053

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

M D Anderson Cancer Center, Houston, Texas, United States

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About this study

PRIMARY OBJECTIVES:

I. To determine the predictive value of advanced imaging modalities Tc99m sestamibi (technetium Tc-99m sestamibi) molecular breast imaging (MBI) and dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) for neoadjuvant chemotherapy (NAC) response in triple negative breast cancer (TNBC).

SECONDARY OBJECTIVES:

I. To evaluate and compare the ability all imaging modalities including standard of care digital mammogram (DM) and ultrasound (US) as well as novel modalities DCE-MRI and MBI to assess and predict response to neoadjuvant chemotherapy (NAC) in patients with triple negative breast cancer (TNBC).

EXPLORATORY OBJECTIVES:

I. To determine effect of molecular subtype of TNBC on diagnostic performance of different types of imaging modalities in predicting treatment response.

II. To determine the Utility of Dynamic Tc99m sestamibi MBI and DCE-MRI together with molecular profiling to identify a subgroup of chemoresistant TNBC patients.

OUTLINE:

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure

Undergo DCE-MRI

Other names: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

laboratory biomarker analysis

Other

Correlative studies

Scintimammography

Radiation

Undergo MBI

Other names: Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test, Molecular Breast Imaging, Nuclear Medicine Breast Imaging, sestamibi breast imaging, Sestamibi Scintimammography

Technetium Tc-99m Sestamibi

Drug

Given via injection

Other names: 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)

    Time frame: Up to 4 years

    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.

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

    Time frame: up to 6 months

    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.

  3. Tumor response assessed by pathological examination

    Time frame: Up to 4 years

    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).

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

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Multimodality Breast Imaging for the Assessment of Tumor Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Apr 20, 2016
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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