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Estrogen Receptor NegativeEarly Phase 1NCT02744053

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

A Early Phase 1 study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Laboratory Biomarker Analysis and Scintimammography in people with Estrogen Receptor Negative and HER2/Neu Negative, run by M.D. Anderson Cancer Center at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Laboratory Biomarker Analysis and Scintimammography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
6 sitesUnited States
Study dates
7 Nov 2016to 30 Apr 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson in Katy

    Houston, Texas, 77094

  • MD Anderson League City

    Nassau Bay, Texas, 77058

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • MD Anderson in The Woodlands

    The Woodlands, Texas, 77384

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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).

Being tested
Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Laboratory Biomarker Analysis, Scintimammography, Technetium Tc-99m Sestamibi
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

    Undergo DCE-MRI

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • ScintimammographyRadiation

    Also called Breast-Specific Gamma Imaging, MBI, Miraluma Scan, Miraluma Test

    Undergo MBI

  • Technetium Tc-99m SestamibiDrug

    Also called Cardiolite, Miraluma, Tc 99m Sestamibi, Tc-99m MIBI

    Given via injection

Study groups in NCT02744053
Study groupRoleWhat they receive
Diagnostic (DCE-MRI, MBI)ExperimentalPatients 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).
Receives: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Other: Laboratory Biomarker Analysis; Radiation: Scintimammography; Drug: Technetium Tc-99m Sestamibi

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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).

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2016 (estimated)
  2. Study start7 Nov 2016
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02744053
Sponsor's protocol ID
2015-0816
Other IDs
NCI-2016-00715, 2015-0816, P30CA016672
Status last verified
Oct 2026
First submitted
5 Apr 2016
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Laboratory Biomarker Analysis and Scintimammography in people with Estrogen Receptor Negative and HER2/Neu Negative, run by M.D. Anderson Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02744053.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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