Using MRI to improve breast cancer imaging

TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer

This study is testing a new MRI technique to see if it can help doctors better understand breast cancer by spotting areas of tumors that might spread more easily after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 95 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Montefiore Medical Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (The Bronx, New York)
• Trial ID: NCT03694756 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the feasibility of a new imaging technology called TMEM-MRI for managing breast cancer. TMEM-MRI can detect areas of tumors that are more permeable, indicating a higher likelihood of cancer spreading. The study will assess the correlation between TMEM doorway density and TMEM MRI activity in patients who have undergone neoadjuvant therapy. By identifying tumors with high leakiness, this technology may help predict recurrence and assess treatment response over time.

Who should consider this trial

Good fit: Ideal candidates include patients with biopsy-proven invasive breast carcinoma or those with highly suspicious breast masses.

Not a fit: Patients who have already started preoperative therapy for their breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging technology could lead to better management and treatment outcomes for breast cancer patients.

How similar studies have performed: Previous studies have indicated that imaging techniques similar to TMEM-MRI may provide valuable prognostic information, suggesting potential success for this novel approach.

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.

Where this trial is running

The Bronx, New York

• Montefiore Medical Center — The Bronx, New York, United States (Recruiting)

Study contacts

• Principal investigator: Jesus Anampa, MD, MS — Montefiore Medical Center
• Study coordinator: Jesus Anampa, MD, MS

Conditions Breast Cancer; TMEM; Magnetic resonance imaging