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Normal Tissue Oxygenation Following Radiotherapy


N/A
18 Years
N/A
Not Enrolling
Female
Radiation Oncology

Thank you

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 HealthDuluth, Minnesota  55805