MedDataX Logo

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

NCT ID: NCT02380209

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

breast cancer CEST MRI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Optimization

CEST MRI of the breast for estimation of tumor pH.

Group Type EXPERIMENTAL

CEST MRI

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CEST MRI

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

iopromide Ultravist Isovue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pavani Chalasani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Cancer Center at UMC North

Tucson, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1406349968

Identifier Type: -

Identifier Source: org_study_id