Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

Carcinoma, Basal Cell Clinical Trial

— HPOB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455363
• Other study ID #: IC 2011-01
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: April 3, 2012
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: September 2011
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18

• Histologically proved cutaneous BCC

• Patient being informed and having signed the consent to participate to the study

Exclusion Criteria:

• Counter-indication to surgery

• Patient being unable to attend future follow-up visits

• Patient with severe cognitive impairment

• Patient not affiliated to a social security regimen

• Patient with limb BCC and history of peripheral vascular artery surgery like bypass and/or vascular prothesis on the same limb (tourniquet counter-indication)

• Local bone invasion of BCC detected with imagery

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carcinoma, Basal Cell

Intervention

Procedure:
• BCC surgery
This clinical trial will use skin flap model for trunk and facial 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.

Other:
• Tourniquet ischemia
In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.
• Laser speckle imaging
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.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of blood perfusion of tumor as ROI (Region Of Interest)	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.	5 months	No