Post-occlusive Reactive Hyperemia and Basal-cell Carcinoma (HPOB)

April 3, 2012 updated by: Institut Curie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75005
        • Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

  • Principal Investigator: GUILHARD Thierry, MD, Institut Curie - Hôpital René Huguenin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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