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Completed

NCT Number: NCT01738217

Assessment of Indocyanine Green as a Near-Infrared Fluorescent Contrast Agent for Image-guided Liver Surgery

This is a prospective, monocentric, non-randomized, phase I-II study. The goal is to assess the faisability and the capabilities of fluorescence imaging in hepatic surgery, and specially to help the surgeon while performing liver surgery.

This study will be performed on patient intended to undergo a liver cancer surgery.It will contain three steps, assessing the following items:

* Step 1: to assess the faisability of the use of the Fluobeam, in actual clinical surgical conditions and validate the data obtained in the preclinical phase, * Step 2: to assess the ability of the combination of ICG and Fluobeam to mark hepatic lesions, * Step 3: to assess the ability of the combination of ICG and Fluobeam to help in guiding per-hepatectomy.

3 to 6 patients will be enrolled in the first step, 20 in the second step and 20 in the third step.

Patients will be followed during 4 weeks after the surgery.

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Key information

Conditions

Liver Neoplasms Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Léon Bérard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patient
  • Affected of hepatic cancerous lesions whatever they are
  • Requiring a one or two steps hepatectomy by laparotomy
  • ECOG performance status (PS)≤ 2
  • Mandatory affiliation to health security insurance
  • Written informed consent

Exclusion criteria

  • With a contraindication or hypersensitivity to ICG administration in medical history
  • Having already undergone a major hepatic surgery (more than three segments) or major biliar surgery (context of major iterative hepatic surgery)
  • Unable to be followed during the duration of the study, for social, family, geographical or psychological reasons
  • Pregnant or breast-feeding woman (urinary strip must be negative at the time of the inclusion in the study for women in age to procreate)

Treatment and study plan

Fluobeam

Procedure

Primary outcomes

  1. First step: assess the feasibility and the acceptability of Fluobeam

    Time frame: During surgery on day 0

    • The ability to detect fluorescence
    • The ability to investigate the mobilized parenchyma
    • The ability to use the medical device following requested asepsis procedures
    • Surgeon satisfaction
    • Nurse satisfaction

  2. Second step: assess the rate of patients in whom, all of the lesions (superficial/deep) will be detected by means of the Fluobeam medical device in peroperative or in postoperative.

    Time frame: During surgery on day 0

  3. Third step: assess the rate of patients in whom, among the 7 liver segments, the surgeon will be able to selectively target a predefined area.

    Time frame: During surgery on day 0

Secondary outcomes

  1. First step: assess the ability to visualize the fluorescent anatomical areas

    Time frame: During surgery on day 0

  2. First step: Quantify the fluorescence

    Time frame: After the surgery, on day 0

    by using the images obtained during the surgery

  3. First step: assess the ability to review saved data

    Time frame: After the surgery, on day 0

  4. Second step: assess the ability to detect tumor lesions which were not previously known.

    Time frame: During surgery on day 0

    Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis.

  5. Second step: assess the rate of modifications of the surgical plan.

    Time frame: During surgery on day 0

    Number of patients for whom the surgery would be modified after using Fluobeam.

  6. Second step: assess the quality of the resection margins.

    Time frame: After the surgery on day 0

    It will be measured using the residual fluorescence and the pathology analysis

  7. Second step: assess the depth limit of detection of the fluorescence.

    Time frame: After the pathology analysis on day 0

    It will be assessed after the anatomopathological analysis.

  8. Second step: Quantify the fluorescence.

    Time frame: After the surgery, on day 0

    From images obtained during the surgery and from the sample analysed by a pathologist.

  9. Second step: assess the number of asepsis due to Fluobeam

    Time frame: During surgery on day 0

  10. Third step: assess the ability to detect tumor lesions which were not previously known.

    Time frame: During surgery on day 0

    Assessment of the number of lesions detected thanks to the medical device. The malignant aspect must be confirmed by an anatomopathological analysis

  11. Third step: quantify the fluorescence.

    Time frame: After the surgery on day 0

    From images obtained during the surgery and from the sample analysed by a pathologist.

  12. Third step: assess the ability to administer two doses of ICG in the same patient

    Time frame: On day 0

    one before and one during the surgery (tumor detection and segment targeting respectively).

  13. Third step: assess the number of asepsis due to Fluobeam

    Time frame: During surgery on day 0

  14. Third step: assess the ability of the medical device to detect tumor lesions which were previously known.

    Time frame: On day 0

    Number of lesions seen on images before and during the surgery and detected by Fluobeam.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

Evaluation, for Patients Requiring a Liver Cancer Surgery, of the Use of Fluorescence Imaging Device: Faisability and Efficiency of Lesional and/or Anatomical Marking

Acronym: HEPATOFLUO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 30, 2012
Registry last updated
Jul 8, 2015

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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