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TerminatedNCT01934114Updated Apr 28, 2016

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

An observational study in Breast Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Terminated at 1 site in United States. Open to female participants aged 25 Years to 76 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-28.

Sponsored by Dartmouth-Hitchcock Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
25 Years to 76 Years
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 8 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 76 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

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.

    Time frame: 18 weeks approximately

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Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01934114
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Sponsor
First posted
Sep 4, 2013
Start date
Aug 2010
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Apr 28, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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