Your session is about to expire
← Back to Search
Imaging Technology
TMEM-MRI Imaging for Breast Cancer (TMEM-MRI Trial)
N/A
Recruiting
Led By Jesus Anampa, MD,MS
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For pre-pilot phase (MRI sequence development): 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 B: Patients with a breast mass found to be invasive ductal carcinoma on core biopsy. The tumor should be considered operable by the breast surgeon. No preoperative therapy for the current breast cancer is planned (endocrine therapy, chemotherapy, or radiation). 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. 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. 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up it will take you about 24 months to complete this research study outcome.
Awards & highlights
TMEM-MRI Trial Summary
This trial assesses whether a new MRI technology can help manage breast cancer.
Who is the study for?
This trial is for adults over 18 with a breast mass larger than 1 cm, diagnosed as invasive breast carcinoma or highly suspicious of it. It's for those who haven't had preoperative therapy and can undergo an MRI with contrast, without any history of severe claustrophobia, metallic implants incompatible with MRI, sickle cell disease, known allergies to gadolinium, or renal impairment.Check my eligibility
What is being tested?
The study is testing the feasibility of TMEM-MRI technology in managing operable breast cancer. Participants will undergo a 'research breast MRI' using this new imaging technique alongside standard care to see how well it works in detecting and assessing their cancer.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort from lying still during the MRI procedure, reactions to gadolinium contrast like nausea or headache (rare), and anxiety related to being in a confined space.
TMEM-MRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a breast mass confirmed as invasive breast cancer by biopsy.
Select...
Criterion: For a specific part of the trial, participants must have a breast mass that is confirmed to be invasive ductal carcinoma through a core biopsy. The tumor should be able to be removed by surgery, and no treatment before surgery is planned. The tumor should be at least 1 cm in size. Participants must be at least 18 years old, have good performance status, be willing to undergo a research breast MRI with contrast, and meet certain medical requirements, such as having no metal objects in the body and no history of certain medical conditions.
TMEM-MRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ it will take you about 24 months to complete this research study outcome.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~it will take you about 24 months to complete this research study outcome.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor permeability assessed by TMEM-MRI
Secondary outcome measures
MenaCalc
MenaInv
TMEM density in breast cancer patients.
TMEM-MRI Trial Design
2Treatment groups
Experimental Treatment
Group I: Pre-biopsy patientsExperimental Treatment2 Interventions
Patients identified by a radiologist at the time of diagnostic evaluation. Once consent is obtained, the TMEM-MRI will be scheduled. After TMEM-MRI, the patient will undergo core biopsy as per usual radiology procedure, with additional FNA at the time of core biopsy (preceding the core biopsy). MenaINV and MenaCalc will be calculated from the FNA material. After the breast biopsy confirms the suspected diagnosis of invasive breast carcinoma, the patient will be referred to breast surgery and a treatment plan devised, as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be also calculated from the specimen obtained at the time of definitive surgery. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.
Group II: Post-biopsy patientsExperimental Treatment1 Intervention
Patients after breast biopsy. Once consent is obtained, patients will undergo TMEM-MRI. The patients will undergo definitive breast surgery and will receive adjuvant treatments as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be evaluated in final surgical specimen. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
444 Previous Clinical Trials
582,485 Total Patients Enrolled
8 Trials studying Breast Cancer
1,252 Patients Enrolled for Breast Cancer
Jesus Anampa, MD,MSPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a breast mass confirmed as invasive breast cancer by biopsy.My breast mass is highly likely to be cancer, as per my radiologist.Criterion: For a specific part of the trial, participants must have a breast mass that is confirmed to be invasive ductal carcinoma through a core biopsy. The tumor should be able to be removed by surgery, and no treatment before surgery is planned. The tumor should be at least 1 cm in size. Participants must be at least 18 years old, have good performance status, be willing to undergo a research breast MRI with contrast, and meet certain medical requirements, such as having no metal objects in the body and no history of certain medical conditions.I have never had breast cancer or radiation to the same breast before.
Research Study Groups:
This trial has the following groups:- Group 1: Pre-biopsy patients
- Group 2: Post-biopsy patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor currently accept new participants?
"As per clinicaltrials.gov, this experiment is currently in the recruitment phase for participants. The trial was first launched on December 12th 2018 and latest edits to its information were made on July 29th 2022."
Answered by AI
How many participants are currently involved in this research trial?
"Affirmative. Clinicaltrials.gov indicates that, since it was first posted on December 12th 2018, the research is currently looking for recruits. A total of 41 individuals need to be gathered from a single site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger