Implantation of CEST and CESL MRI Methods for Detection of Breast Tumors

NCT05305937 | Unknown FDA Device

• 1 other identifier: 0201-21
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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-CT fulfills this gap but suffers from low resolution and the risk of radiation damage. Lately, chemical exchange saturation transfer (CEST) MRI of glucose has been proposed as a new molecular imaging approach for diagnosing tumors given its high sensitivity at the molecular level and the known enhanced glucose uptake by tumors. Several glucose analogs were examined as possible candidates for imaging of breast tumors. One of the most promising agent for CEST-MRI is glucosamine (GlcN); owing to its phosphorylated products that accumulate in breast tumors, it enables to reflect their metabolic profile. In preclinical experiments glucosamine exhibits enhanced CEST signals in 4T1 and MCF7 implanted breast cancer cells in mice. Its potential for the human clinical application is strengthened by its lack of toxicity. Here the investigators propose to test the method for human subjects on a clinical MRI setup. The goal of this study is to develop innovative molecular imaging modality based on CEST-MRI of GlcN for the detection of breast tumors. The investigators will use the newly developed CEST-MRI modality for the detection of benign and malignant breast cancer in a clinical MRI scanner. .

Conditions

Malignant Tumor of Breast; Benign Breast Lumps; High-Risk Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Detection and diagnosis of malignant tumors in the breast

  Detection and diagnosis of malignant tumors in the breast without the use of gadolinium contrast agent. The proposed GlcN CEST MRI method is based on the ability of tumors to accumulate glucosamine in a preferred manner (Warburg effect). Therefore, the new method allows the acquisition of new information that is not obtained by other imaging methods: the method allows the presentation of a new contrast image in MRI that expresses metabolic changes in the tumor, expressed as % GlcN CEST.

  up to three years (MRI scans and data collection and interpretation will last up to 2 years; post processing, reports and publications will last about one more year)

Secondary Outcomes (4)

• Tumor classification: benign or malignant

  3 years (data collection and post processing)

• Glucosamine CEST scale bar

  Three years (data collection and post processing)

• Finding correlation between research results and selected pathological parameters to better identify breast cancer

  3 years (data collection and statistical evaluation)

• Using Mathematical model

  up to 3 years (post processing-1 year)

Study Arms (1)

One arm - all patients

EXPERIMENTAL

Device: MRI scan

Interventions

MRI scan DEVICE

All patients will be scanned twice during the same MRI session, before and 2 hours after taking glucosamine orally. In addition to the CEST scans with glucosamine, patients will undergo MRI scans with the standard contrast agent of gadolinium. This procedure will be done following the CEST scan

One arm - all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead
• Tel Aviv University: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology department

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: March 31, 2022

Record last verified: 2022-03