Normal Tissue Oxygenation Following Radiotherapy
18 Years
N/A
Female
Radiation Oncology
Trial Information
Normal Tissue Oxygenation Following Radiotherapy
Successful completion of this study will provide data on changes in oxygenation in
irradiated tissues. If changes are documented, this study would provide evidence supporting
current models of tissue injury following radiotherapy. In addition, these data may provide
a mechanistic rationale for clinical approaches to ameliorate the toxicities of
radiotherapy. Finally, if a correlation exists between tissue oxygenation and toxicity, the
rapid and simple tissue oxygenation test may provide a quantitative measure of toxicity and
allow earlier and more precise assessment of both toxicity and efficacy of ameliorative
therapies.
Inclusion Criteria:
1. Diagnosis of breast malignancy
2. Completion of breast irradiation one year (+/- 8 weeks) prior.
3. Surgical treatment with lumpectomy
Exclusion Criteria:
1. Inability to tolerate the 20 minute transcutaneous oxygenation measurements
2. Allergy to adhesives
3. Bilateral disease or absence of control breast or previous radiotherapy to "control"
breast
4. More than one course of radiotherapy to the breast
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.
Outcome Time Frame:
One visit for 20 minutes
Safety Issue:
No
Principal Investigator
Kenneth L Dornfeld, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Essentia Health
Authority:
United States: Institutional Review Board
Study ID:
030804
NCT ID:
NCT00677040
Start Date:
April 2008
Completion Date:
August 2009
Related Keywords:
- Radiation Oncology
Name | Location |
|---|---|
| Essentia Health | Duluth, Minnesota 55805 |
