Clinical trial

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

Name

2015-0816

Description

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.

Trial arms

Trial start

2016-11-07

Estimated PCD

2026-04-30

Trial end

2026-04-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI

Arms:

Diagnostic (DCE-MRI, MBI)

Other names:

DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

Laboratory Biomarker Analysis

Correlative studies

Arms:

Diagnostic (DCE-MRI, MBI)

Scintimammography

Undergo MBI

Arms:

Diagnostic (DCE-MRI, 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

Given via injection

Arms:

Diagnostic (DCE-MRI, MBI)

Other names:

Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI, Tc99m Sestamibi

Size

Primary endpoint

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)

Up to 4 years

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

up to 6 months

Tumor response assessed by pathological examination

Up to 4 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}

Updated at

2024-04-23

1 organization

1 product

4 indications

Organization

M.D. Anderson Cancer Center

Product

Technetium Tc-99m Sestamibi

Indication

Estrogen Receptor Negative

Indication

HER2/Neu Negative

Indication

Progesterone Receptor Negative

Indication

Triple-Negative Breast Carcinoma