Suspended

Alternative Imaging Methods for Monitoring Neoadjuvant Therapy Response in Locally-Advanced Breast Cancer

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2006
See protocol details

Summary

Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: September 30, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2006

Actual date on which the first participant was enrolled.

This study focuses on women with locally-advanced breast cancer who are receiving treatment. The main goal is to find out if four new imaging techniques can effectively monitor how the cancer responds to the treatment. These techniques include MRI Elasticity Imaging (MRE), Electrical Impedance Spectroscopy (EIS), Microwave Imaging and Spectroscopy (MIS), and Near Infrared Spectroscopy (NIR). These methods create pictures of the inside of the breast, helping doctors see if the cancer is shrinking. The study also involves comparing these new methods to each other and to current standard imaging techniques. During the study, participants undergo imaging using the four new methods and possibly additional standard imaging techniques like contrast-enhanced MRI and mammography. These extra exams are only done if they are medically necessary for the patient's care. The study's primary outcome is to compare changes seen in the new imaging methods with changes seen in the standard methods. This comparison helps researchers understand if the new methods accurately show how the cancer responds to treatment.

Principal SponsorDartmouth-Hitchcock Medical Center
Last updated: September 30, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
Age >= 18 years old

Breast size and epithelial integrity adequate to allow alternate imaging exams

Locally advanced breast cancer, with or without metastatic disease

No serious associated psychiatric illness

Show More Criteria

4 exclusion criteria prevent from participating
Allergy to the MRI contrast agent gadolinium

Any implanted electronic device

Cardiac pacemaker

Severe claustrophobia

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Dartmouth-Hitchcock Medical Center

Lebanon, United StatesOpen Dartmouth-Hitchcock Medical Center in Google Maps
SuspendedOne Study Center