Clinical trial · Interventional
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
Multimodality Breast Imaging for the Assessment of Tumor Response to Neoadjuvant Chemotherapy in Triple Negative Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Negative | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Progesterone Receptor Negative | — | UNRESOLVED | — |
| Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Scintimammography | Radiation | — | UNRESOLVED |
| Technetium Tc-99m Sestamibi | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (DCE-MRI, MBI)
- description
- 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).
- interventionNames
- Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Other: Laboratory Biomarker Analysis
- Radiation: Scintimammography
- Drug: Technetium Tc-99m Sestamibi
Primary outcomes (3)
- measure
- 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)
- timeFrame
- Up to 4 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available