Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

NCT01455363 | Completed

• 1 other identifier: IC 2011-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Basal Cell

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

BCC surgery PROCEDURE

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.

Tourniquet ischemia OTHER

In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.

Laser speckle imaging OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Histologically proved cutaneous BCC
• Patient being informed and having signed the consent to participate to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

Related Publications (1)

• Reyal J, Lebas N, Fourme E, Guihard T, Vilmer C, Le Masurier P. Post-occlusive reactive hyperemia in basal cell carcinoma and its potential application to improve the efficacy of solid tumor therapies. Tohoku J Exp Med. 2012 Jun;227(2):139-47. doi: 10.1620/tjem.227.139.

  PMID: 22706476 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GUILHARD Thierry, MD

  INSTITUT CURIE - HOPITAL RENE HUGUENIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 19, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

FR (1)