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

University of Arizona

Status and phase: Terminated; Early Phase 1

Conditions: Breast Cancer

Treatments: Other: CEST MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02380209

1406349968

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Optimization

Experimental group

Description:

CEST MRI of the breast for estimation of tumor pH.

Treatment:

Other: CEST MRI