An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Study Overview
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Brief Summary
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Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.

Detailed Description
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Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either. This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.

Official Title
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An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: CEST MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast >= 1.0 cm primary tumor Calculated creatinine clearance >= 50 mL/min Willing and able to provide informed consent Age ≥ 18 years ECOG performance status 0-2 Informed of the investigational nature of this study Exclusion Criteria: Allergy to iodinated contrast agent Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs Diabetes mellitus History of severe claustrophobia Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI Use of > 1 antihypertensive drug Pregnancy or breastfeeding Paraproteinemia syndromes or multiple myeloma Collagen vascular disease Active hyperthyroidism Active pharmaceutical treatments for cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimization<br>CEST MRI of the breast for estimation of tumor pH. | Other: CEST MRI<br>* CEST MRI will be performed on patients prior to surgical resection of their tumor<br>* Other names: Isovue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH measurement of the tumor will be measured by the CEST MRI. | pH estimate of the tumor | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia. |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, CEST MRI