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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
CEST MRI
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, CEST MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Arizona Cancer Center at UMC North

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optimization

Arm Description

CEST MRI of the breast for estimation of tumor pH.

Outcomes

Primary Outcome Measures

pH measurement of the tumor will be measured by the CEST MRI.
pH estimate of the tumor

Secondary Outcome Measures

Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.

Full Information

First Posted
January 9, 2015
Last Updated
October 25, 2016
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02380209
Brief Title
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
Official Title
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, CEST MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimization
Arm Type
Experimental
Arm Description
CEST MRI of the breast for estimation of tumor pH.
Intervention Type
Other
Intervention Name(s)
CEST MRI
Other Intervention Name(s)
iopromide, Ultravist, Isovue
Intervention Description
CEST MRI will be performed on patients prior to surgical resection of their tumor
Primary Outcome Measure Information:
Title
pH measurement of the tumor will be measured by the CEST MRI.
Description
pH estimate of the tumor
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavani Chalasani, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Cancer Center at UMC North
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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