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

October 25, 2016 updated by: University of Arizona
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at UMC North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optimization
CEST MRI of the breast for estimation of tumor pH.
Other: CEST MRI
CEST MRI will be performed on patients prior to surgical resection of their tumor
Other Names:
  • Isovue
  • iopromide
  • Ultravist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH measurement of the tumor will be measured by the CEST MRI.
Time Frame: 2 weeks
pH estimate of the tumor
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1406349968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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