Clinical trial · Interventional
Implantation of CEST and CESL MRI Methods for Detection of Breast Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Lumps | — | UNRESOLVED | — |
| High-Risk Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Tumor of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- One arm - all patients
- interventionNames
- Device: MRI scan
Primary outcomes (1)
- measure
- Detection and diagnosis of malignant tumors in the breast
- timeFrame
- 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)
- description
- 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.
Secondary outcomes (4)
- measure
- Tumor classification: benign or malignant
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with suspicious finding/process in the breast that requires MRI examination 2. Age: Over 18 years. 3. 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 Criteria: 1. Pregnancy or breastfeeding 2. Sensitivity to glucosamine and / or gadolinium. 3. Renal failure with creatinine clearance less than 30 cc per minute. 4. Weight over 130 kg. 5. Patients who have undergone breast surgery in the past year. 6. Claustrophobia. 7. Cardiovascular instability, symptomatic heart disease, pacemaker, artificial heart valve. 8. Intra-body injection device. 9. A generalized (idiopathic) epileptic seizure that is pharmacologically unbalanced. 10. Metabolic instability (water economy, electrolytes, sugar). 11. Suffers from a gastrointestinal disorder that affects absorption. 12. Fever or evidence of a microbiological contaminant. 13. Women using drugs that are related to derivatives of warfarin-coumadin. 14. Women with phenylketonuria 15. Inability to sign informed consent. 16. 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.
References
Publications (0)
Data not yet available