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

NCT01934114 | Terminated DMC

• 1 other identifier: D1025
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 25 Years - 76 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• NORMAL cohort
• Breast size and epithelial integrity adequate to allow NIR imaging exams
• No serious associated psychiatric illnesses
• Female, ≥25 and \<76 years old
• Written informed consent
• UNDER TREATMENT cohort
• Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy
• Breast size and epithelial integrity adequate to allow NIR imaging exams
• No serious associated psychiatric illnesses
• Female, ≥25 and \<76 years old
• Written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: September 4, 2013
• Study Start: August 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2015-01

Locations

US (1)