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New treatment option for Breast Cancer
Official title TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
ClinicalTrials.gov ID: NCT03694756
What this study is testing
- What it's testing
- The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer - Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For pre-pilot phase (MRI sequence development): o Patients with a breast mass, with biopsy-proven histology of invasive breast carcinoma (any...
- For pilot phase Cohort A: o Patients with a breast mass considered highly suspicious for invasive carcinoma by the radiologist (BIRADS 5).
- For pilot phase Cohort B:
- Patients with a breast mass found to be invasive ductal carcinoma on core biopsy.
- No preoperative therapy for the current breast cancer has been started (endocrine therapy, chemotherapy, or radiation). Patients can receive...
You likely can't join if
- Patients may not have had breast cancer or radiation therapy to the ipsilateral breast in the past.
- No breast prosthetic implants (silicone or saline) are allowed.
- Use of any investigational agent within 30 days of starting study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.
See the full eligibility criteria
- For pre-pilot phase (MRI sequence development): o Patients with a breast mass, with biopsy-proven histology of invasive breast carcinoma (any histologic type and ER,PR,HER2 status)
- For pilot phase Cohort A: o Patients with a breast mass considered highly suspicious for invasive carcinoma by the radiologist (BIRADS 5).
- For pilot phase Cohort B:
- Patients with a breast mass found to be invasive ductal carcinoma on core biopsy.
- No preoperative therapy for the current breast cancer has been started (endocrine therapy, chemotherapy, or radiation). Patients can receive preoperative treatment after TMEM-MRI is conducted, if clinically indicated.
- For pilot phase Cohort C:
- Patients with locally advanced breast cancer, anatomic stage II-III, who received neoadjuvant therapy as per standard of care.
- Residual palpable mass \> 1 cm in largest diameter after neoadjuvant therapy.
- Candidate for breast MRI before definitive surgery.
- Tumor size/breast mass should be \> 1 cm in largest diameter (radiologically).
- Multifocal disease is allowed, as long as patients meet all eligibility criteria.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Willingness to undergo a "research breast MRI".
- Patient must be able to undergo MRI with gadolinium enhancement.
- No history of untreatable claustrophobia.
- No presence of non-MRI compatible metallic objects or metallic objects that, in the opinion of a radiologist, would make MRI a contraindication.
- No history of sickle cell disease.
- No contraindication to intravenous contrast administration.
- No known allergy-like reaction to gadolinium
- No known or suspected renal impairment. Glomerular Filtration Rate (GFR) should be greater than 30 mL/min/1.73 m2.
- Weight less than or equal to the MRI table limit.
- Ability to understand and willingness to sign a written informed consent.
- Patients may not have had breast cancer or radiation therapy to the ipsilateral breast in the past.
- No breast prosthetic implants (silicone or saline) are allowed.
- Use of any investigational agent within 30 days of starting study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.