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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02380209

Enrollment

Registered

2015-03-05

Start date

2014-08-31

Completion date

2016-08-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, CEST MRI

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.

Interventions

OTHERCEST MRI

CEST MRI will be performed on patients prior to surgical resection of their tumor

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
pH measurement of the tumor will be measured by the CEST MRI.	2 weeks	pH estimate of the tumor

Secondary

Measure	Time frame
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026