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NCT02744053
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
Conditions: Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Triple-Negative Breast Carcinoma
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 96
Sponsor: M.D. Anderson Cancer Center
Location: Memorial Hermann Memorial City Medical Center Houston Texas
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02744053). StuddyBuddy aggregates publicly available trial information.