Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455363

Acronym

HPOB

Enrollment

Registered

2011-10-19

Start date

2011-06-30

Completion date

2011-10-31

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Basal Cell

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.

Interventions

PROCEDUREBCC 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.

OTHERTourniquet ischemia

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

OTHERLaser 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of blood perfusion of tumor as ROI (Region Of Interest)	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026