- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380209
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
Study Overview
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center at UMC North
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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CEST MRI will be performed on patients prior to surgical resection of their tumor
Other Names:
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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
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pH estimate of the tumor
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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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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