Using MRI to improve breast cancer imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: janampa@montefiore.org
• Phone: 7184058505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.