DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Brea… (NCT02744053) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
United States96 participantsStarted 2016-11-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an Early Phase 1 trial that is no longer enrolling new patients, is there a follow-up or next-phase study I might be eligible for that uses these same imaging techniques — DCE-MRI or molecular breast imaging — to track how my tumor responds to chemotherapy?
2This trial is specifically for triple-negative breast cancer and uses MBI with a radioactive tracer called Tc99m-sestamibi alongside standard imaging like ultrasound and mammogram — how do these imaging approaches compare in their ability to show whether my tumor is responding to chemo, and is any of this available to me outside of a trial?
3Because this study focuses on measuring tumor response during chemotherapy rather than testing a new drug, would participating in something like this change my actual treatment plan at all, or is it purely observational?
4The trial tracks whether imaging results match what's found when pathologists examine the tumor after treatment — based on what's been learned so far from studies like this, does my care team use DCE-MRI or MBI results to guide my chemotherapy decisions, and should they?
5Triple-negative breast cancer is known to be aggressive, so how do you weigh the time and logistics of additional imaging visits — which a study like this would require — against focusing on moving quickly with standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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)
Timeframe: Up to 4 years
2
Percent change in tumor volume assessed by dynamic Tc99m-sestamibi MBI
Timeframe: up to 6 months
3
Tumor response assessed by pathological examination