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

I

Institut Curie

Status

Completed

Conditions

Carcinoma, Basal Cell

Treatments

Procedure: BCC surgery
Other: Tourniquet ischemia
Other: Laser speckle imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT01455363
IC 2011-01

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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