Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

NCT ID: NCT01455363

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Tourniquet ischemia

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GUILHARD Thierry, MD

Role: PRINCIPAL_INVESTIGATOR

INSTITUT CURIE - HOPITAL RENE HUGUENIN

Locations

Institut Curie

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 22706476 (View on PubMed)

Other Identifiers

IC 2011-01

Identifier Type: -

Identifier Source: org_study_id