Intra tumoral Oxygenation; A Predictor for Treatment outcome in Cervical Cancer.
- Conditions
- cervical cancer10038597
- Registration Number
- NL-OMON29843
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1. Histologically proven carcinoma of the uterine cervix
(primary tumor: FIGO stages I-IV, or local recurrence),
2. Age >18 years,
3. Written informed consent.
Exclusion Criteria
1. Patients without a tumor accessible by vaginal inspection,
2. Patients with severe vaginal blood loss,
3. Patients with psychosocial or somatic disorders in the medical history limiting the possibilities for adequate follow-up,
4. Patients with a pacemaker or other metal objects not suitable for MRI
5. Patients unable to receive propofol anesthesia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. feasibility of techniques<br /><br>2. Oxygenation parameters (appendix 1:<br /><br>P50 value<br /><br>HP 2.5<br /><br>HP 5.0<br /><br>HP 10.0<br /><br>Ktrans (exchange rate)<br /><br>Ve (extravascular volume)<br /><br>OER (Oxygen Extraction Ratio)<br /><br>Gene expression profiles<br /><br>HIF-1*<br /><br>CA-9<br /><br>Lactate<br /><br>PAI-1<br /><br>osteopontin<br /><br>D-dimer<br /><br>VEGF<br /><br>bFGF<br /><br>TGF-*<br /><br>TNF-*<br /><br>IL-8<br /><br>Local control<br /><br>Failure free survival<br /><br>Overall survival<br /><br>Acute toxicity<br /><br>Late toxicity</p><br>
- Secondary Outcome Measures
Name Time Method <p>Local control<br /><br>Failure free survival<br /><br>Overall survival<br /><br>Acute toxicity<br /><br>Late toxicity</p><br>