An Early Phase 1 interventional study of CEST MRI in Breast Cancer, sponsored by University of Arizona. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by University of Arizona · Early Phase 1, Interventional, and Diagnostic
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: iopromide, Ultravist, Isovue
pH measurement of the tumor will be measured by the CEST MRI.
pH estimate of the tumor
Time frame: 2 weeks
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
Time frame: 2 weeks
This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Arizona