NCT03694756 TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
| NCT ID | NCT03694756 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2018-12-12 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 95 participants in total. It began in 2018-12-12 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion 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. Exclusion Criteria * 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 that would limit compliance with study. * Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.
Contact & Investigator
Jesus Anampa, MD, MS
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT03694756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03694756 currently recruiting?
Yes, NCT03694756 is actively recruiting participants. Contact the research team at janampa@montefiore.org for enrollment information.
Where is the NCT03694756 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT03694756 clinical trial?
NCT03694756 is sponsored by Montefiore Medical Center. The principal investigator is Jesus Anampa, MD, MS at Montefiore Medical Center. The trial plans to enroll 95 participants.
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