Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma (HPOB)
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|ClinicalTrials.gov Identifier: NCT01455363|
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : April 4, 2012
The investigators aim to test the hypothesis and to proof thank to laser speckle contrast imaging that post-occlusive reactive hyperemia (PORH) can be induced through a tumor, in this case, through a basal cell carcinoma, which will be used as a model of study of tumor vasculature.
This new concept of tumor perfusion artificial increase could be used in the future for malignant tumors treatment, in order to increase tumor mean oxygen partial pressure (thus decreasing tumor hypoxia, hallmark of malignant tumors) during cancerology therapies, like radiotherapy and/or chemotherapy, and increase their efficacy.
This clinical trial will use skin flap model for trunk and facial basal cell carcinoma (BCC), with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.
In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.
During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Basal Cell||Procedure: BCC surgery Other: Tourniquet ischemia Other: Laser speckle imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Etude peropératoire de la Perfusion Sanguine Des Carcinomes Basocellulaires Par Imageur Laser Doppler, au Cours de la Manipulation de l'Influx artériel Tumoral - Recherche d'un phénomène d'hyperémie Tumorale Post-occlusive|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Procedure: BCC surgery
- Evaluation of blood perfusion of tumor as ROI (Region Of Interest) [ Time Frame: 5 months ]Evaluation of blood perfusion of tumor as ROI (Region Of Interest)in unit of laser doppler perfusion, analyzed by the software Pimsoft with the imager laser doppler Pericam PSI system of Perimed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455363
|Paris, France, 75005|
|Principal Investigator:||GUILHARD Thierry, MD||INSTITUT CURIE - HOPITAL RENE HUGUENIN|