NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo

April 26, 2016 updated by: Dartmouth-Hitchcock Medical Center

NIR (Near Infrared Spectral Tomography)Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo.

The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females with locally advanced breast cancer defined as being clinically appropriate for neoadjuvant therapy and healthy volunteers

Description

Inclusion Criteria:

  • NORMAL cohort

    1. Breast size and epithelial integrity adequate to allow NIR imaging exams
    2. No serious associated psychiatric illnesses
    3. Female, ≥25 and <76 years old
    4. Written informed consent

  • UNDER TREATMENT cohort

    1. Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy
    2. Breast size and epithelial integrity adequate to allow NIR imaging exams
    3. No serious associated psychiatric illnesses
    4. Female, ≥25 and <76 years old
    5. Written informed consent

Exclusion Criteria:

  • both cohorts

    1. Pre-existing respiratory conditions:

      1. severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema)
      2. Other respiratory or lung conditions which would place the patient at risk
      3. presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea
    2. Congestive heart failure
    3. Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct breathing circuit
    4. Pregnancy

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Under Treatment
Patients with locally advanced breast cancer, defined as being clinically appropriate for neoadjuvant therapy
Normal Cohort
Healthy female volunteers with breast size and epithelial integrity adequate to allow NIR imaging exams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.
Time Frame: 18 weeks approximately
Analyze captured data from use of dynamic NIR topographic oximetry (in a cohort of women receiving conventional anthracycline/taxane based adjuvant chemotherapy).Quantify pathological and clinical outcomes.
18 weeks approximately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

September 4, 2013

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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