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

Dartmouth Health

Status: Terminated

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01934114

D1025

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 25 to 76 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

8 participants in 2 patient groups

Under Treatment

Description:

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

Normal Cohort

Description:

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