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Completed

NCT Number: NCT01455363

Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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

Acronym: HPOB

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2011
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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