Trials / Withdrawn
WithdrawnNCT01277263
Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging
Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- Female
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Women with Breast Cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome. The Researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. The research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.
Detailed description
The researcher can use Diffuse Optical Spectroscopic Imaging device to measure and predict the markers of the response in the first weeks of chemo-therapy. The oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. These vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration in the first hours and days after therapeutic administration. The magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. This oxyhemoglobin "flare response" can be observed In tumors where vascular dynamics are intact.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Diffuse Optical Spectroscopy Imaging | Monitoring Breast Cancer during chemo therapy |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2011-01-14
- Last updated
- 2022-11-01
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01277263. Inclusion in this directory is not an endorsement.