Clinical trial · Observational
NIR Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo
NIR (Near Infrared Spectral Tomography)Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Under Treatment
- description
- Patients with locally advanced breast cancer, defined as being clinically appropriate for neoadjuvant therapy
- label
- Normal Cohort
- description
- Healthy female volunteers with breast size and epithelial integrity adequate to allow NIR imaging exams
Primary outcomes (1)
- measure
- Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.
- timeFrame
- 18 weeks approximately
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 76 Years
Show eligibility criteria text
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. PregnancyReferences
Publications (0)
Data not yet available