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

Early Phase 1TerminatedNCT02380209

University of Arizona8 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

CEST MRIOTHER

CEST MRI will be performed on patients prior to surgical resection of their tumor

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Arizona Cancer Center at UMC North

Tucson, Arizona, United States

Outcomes

Primary Outcomes

pH measurement of the tumor will be measured by the CEST MRI.

pH estimate of the tumor

Time frame: 2 weeks

Secondary Outcomes

Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.

Time frame: 2 weeks

Data from ClinicalTrials.gov

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