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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02380209
• Other study ID #: 1406349968
• Status: Terminated
• Phase: Phase 0
• First received: January 9, 2015
• Last updated: October 25, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Arizona Cancer Center at UMC North	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pH measurement of the tumor will be measured by the CEST MRI.	pH estimate of the tumor	2 weeks	No
Secondary	Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.		2 weeks	No