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

NCT ID: NCT01934114

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-09-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Under Treatment

Patients with locally advanced breast cancer, defined as being clinically appropriate for neoadjuvant therapy

No interventions assigned to this group

Normal Cohort

Healthy female volunteers with breast size and epithelial integrity adequate to allow NIR imaging exams

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D1025

Identifier Type: -

Identifier Source: org_study_id