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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01934114
• Other study ID #: D1025
• Status: Terminated
• Phase: N/A
• First received: April 17, 2013
• Last updated: April 26, 2016
• Start date: August 2010
• Est. completion date: September 2015

Study information

• Verified date: January 2015
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 76 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.	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	No