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Imaging Techniques for Breast Cancer

Phase < 1
Waitlist Available
Led By Gaiane M Rauch
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial uses DCE-MRI and technetium-Tc99m sestamibi molecular breast imaging (MBI) to assess tumor response to chemotherapy in patients with triple negative breast cancer (TNBC).

Who is the study for?
This trial is for individuals who can consent to participate, have confirmed triple negative breast cancer (TNBC) with no prior treatment, and are enrolled in the clinical trial: 2014-0185. It's not for those with MRI contraindications, pregnant or nursing women, patients with chest wall-involved lesions, allergies to Tc99m sestamibi, or issues with MRI contrast.Check my eligibility
What is being tested?
The study is testing how well DCE-MRI and MBI imaging techniques measure the effectiveness of chemotherapy in TNBC patients. These advanced scans might help predict patient response to treatment before it's visible through standard methods.See study design
What are the potential side effects?
While this trial focuses on imaging techniques rather than drugs, potential side effects may include discomfort during the scan procedure, allergic reactions to dyes used in DCE-MRI or MBI (rare), and anxiety from being in a confined space during MRI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is triple-negative, not showing positive for estrogen, progesterone, or HER2.
Select...
I have triple-negative breast cancer and haven't started treatment yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change in tumor volume assessed by dynamic Tc99m-sestamibi MBI
Neoplasms
Tumor response assessed by pathological examination
Other outcome measures
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (DCE-MRI, MBI)Experimental Treatment4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
2006
Completed Phase 2
~310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,571 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,706 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Gaiane M RauchPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Technetium Tc-99m Sestamibi Clinical Trial Eligibility Overview. Trial Name: NCT02744053 — Phase < 1
Breast Cancer Clinical Trial 2023: Technetium Tc-99m Sestamibi Highlights & Side Effects. Trial Name: NCT02744053 — Phase < 1
Technetium Tc-99m Sestamibi 2023 Treatment Timeline for Medical Study. Trial Name: NCT02744053 — Phase < 1
Breast Cancer Research Study Groups: Diagnostic (DCE-MRI, MBI)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted into this experiment?

"This experiment is no longer recruiting research subjects. Initially posted on the 7th of November, 2016 and last edited February 11th 2022; alternative trials for triple negative breast carcinoma are in abundance with 2355 studies actively enrolling participants, as well as 3 separate Technetium Tc-99m Sestamibi clinical trials looking to onboard patients."

Answered by AI

What other studies have utilized Technetium Tc-99m Sestamibi?

"Currently, Technetium Tc-99m Sestamibi is the subject of 3 active clinical trials with no Phase 3 studies yet. 8 sites scattered across America are running tests for this substance; notably there are numerous Houston locations included in these numbers."

Answered by AI

Are there any unfilled openings in this clinical trial?

"Per clinicaltrials.gov, this study is not presently recruiting patients. Initially posted on November 7th 2016 and last updated February 11th 2022, the trial is unfortunately non-operational at this time; however, 2358 other studies are actively seeking participants as we speak."

Answered by AI

Are there numerous venues hosting this investigation within the state?

"6 locations are participating in this clinical trial, such as MD Anderson in The Woodlands and M D Anderson Cancer Center of Houston. Additionally, there will be centres located in Katy and Nassau Bay."

Answered by AI

What commonly occurring medical condition does Technetium Tc-99m Sestamibi address?

"Technetium Tc-99m Sestamibi is employed to conduct perfusion scintigraphy, and can be useful in managing angina pectoris, thyroid gland issues, or hyperthyroidism."

Answered by AI
~0 spots leftby Apr 2024