Clinical trial NCT02380209: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Keywords: breast cancer
CEST MRI
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: pH measurement of the tumor will be measured by the CEST MRI.
timeFrame: 2 weeks
Secondary outcomes:
measure: Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at UMC North
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References: