Status:
UNKNOWN
Implantation of CEST and CESL MRI Methods for Detection of Breast Tumors
Lead Sponsor:
Meir Medical Center
Collaborating Sponsors:
Tel Aviv University
Conditions:
Malignant Tumor of Breast
Benign Breast Lumps
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
MRI is a well-established method in breast imaging. It gives excellent morphological information but does not reflect the metabolic activity leading to high proportion of false positive results. PET-C...
Detailed Description
The primary aim of this study is to develop innovative molecular imaging modality based on the chemical exchange saturation transfer MRI (CEST-MRI) of glucosamine (GlcN) to visualize and measure breas...
Eligibility Criteria
Inclusion
- Women with suspicious finding/process in the breast that requires MRI examination
- Age: Over 18 years.
- For 10 patients of control group - patients without breast tumor, carriers of mutations in P53, BRCA2, BRCA1 or PTEN genes or women after genetic counseling who have been defined as having a 20% risk of developing breast cancer and are undergoing routine MRI.
Exclusion
- Pregnancy or breastfeeding
- Sensitivity to glucosamine and / or gadolinium.
- Renal failure with creatinine clearance less than 30 cc per minute.
- Weight over 130 kg.
- Patients who have undergone breast surgery in the past year.
- Claustrophobia.
- Cardiovascular instability, symptomatic heart disease, pacemaker, artificial heart valve.
- Intra-body injection device.
- A generalized (idiopathic) epileptic seizure that is pharmacologically unbalanced.
- Metabolic instability (water economy, electrolytes, sugar).
- Suffers from a gastrointestinal disorder that affects absorption.
- Fever or evidence of a microbiological contaminant.
- Women using drugs that are related to derivatives of warfarin-coumadin.
- Women with phenylketonuria
- Inability to sign informed consent.
- COVID-19
- In addition, all examinees will be subject to the accepted criteria for inclusion and exclusion of the MRI unit at Meir Medical Center.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05305937
Start Date
May 1 2022
End Date
May 31 2025
Last Update
March 31 2022
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