Study 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.
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 breast-cancer
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedOctober 27, 2016
October 1, 2016
2 years
January 9, 2015
October 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pH measurement of the tumor will be measured by the CEST MRI.
pH estimate of the tumor
2 weeks
Secondary Outcomes (1)
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
2 weeks
Study Arms (1)
Optimization
EXPERIMENTALCEST MRI of the breast for estimation of tumor pH.
Interventions
CEST MRI will be performed on patients prior to surgical resection of their tumor
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arizona Cancer Center at UMC North
Tucson, Arizona, 85724, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pavani Chalasani, MD
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
March 5, 2015
Study Start
August 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 27, 2016
Record last verified: 2016-10