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

Stopped early · Early Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02380209

Run by

University of Arizona

People needed

8

Starts

2014-08-01

Expected to finish

2016-08-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center at UMC North — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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