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

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01934114
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-08-29
• Study First Posted: 2013-09-04
• Status Verified: 2015-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.	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.

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States