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

Early Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Other: CEST MRI

• Registration Number: NCT02380209
• Lead Sponsor: University of Arizona

Brief Summary

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

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optimization	CEST MRI	CEST MRI of the breast for estimation of tumor pH.

Primary Outcome Measures

Name	Time	Method
pH measurement of the tumor will be measured by the CEST MRI.	2 weeks	pH estimate of the tumor

Secondary Outcome Measures

Name	Time	Method
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.	2 weeks

Trial Locations

Locations (1)

Arizona Cancer Center at UMC North; 🇺🇸 Tucson, Arizona, United States