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Near-Infrared Imaging of Peritoneal Carcinomatosis From Colorectal Cancer (OC-AP-ICG-IV)

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ClinicalTrials.gov Identifier: NCT02032485
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute

Brief Summary:
The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Peritoneal Carcinomatosis Drug: Indocyanine Green Phase 2

Detailed Description:

Primary objective

Evaluation of the ability of NIR imaging using ICG to demonstrate (the gross tumoral mass and/or) peritoneal metastatic " implants " in patients operated for peritoneal carcinomatosis from colorectal carcinoma

Secondary objective:

Definition of the histological distribution (in the vessels, in the extravascular spaces, in specific cells) of IV injected ICG in the normal and pathological tissues (and, if any is demonstrated per-operatively, a) in the nodes of these patients found fluorescent and removed and/or b) at the level of the fluorescent foci observed at the level of the hepatic surfaces)

Methodology:

The day before the operation:

ICG 0.125 mg/kg will be given as an iv injection the day before the operation.

In the operating room:

When the patient will be operated, the surgeons will (under "conventional" video control) search and establish as usual the presence (of "gross" tumoral mass and) of metastatic deposits at the level of the peritoneal surfaces. NIR imaging will be acquired during these manoeuvers and, if detected, fluorescent structures and/or foci will be anatomically defined by the surgeons.

If ("gross" tumoral mass and/or) metastatic deposits are seen fluorescent, the operation will be then continued as usual but each anatomical piece will be controlled "ex vivo" for its fluorescent character or not. All fluorescent foci on these anatomical pieces will be identified as such by a mark and/or by a "suture".

If ("gross" tumoral mass and/or) metastatic deposits are not seen fluorescent, ICG 0.125 mg/kg will be given as an iv injection and the vascularization, income of the ICG in the tumoral implants (judged by the surgeon the most representative of the patient's status) will be dynamically studied using the PDE camera during the 10 minutes following the IV injection.

If no hepatic metastases were pre-operatively documented, the surface of the liver will be controlled and, if superficial fluorescent foci are observed, these will be biopsied.

In the Laboratory of Pathology:

The tumoral tissues as well as -if identified- the "non identified as tumoral" fluorescent tissular foci will be processed as usual.

All the slides obtained will be analyzed using the near-infrared fluorescence microscope for the presence or the absence of (detectable) ICG and the different ICG-positive compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages,…) will be determined.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Colorectal Cancer
Study Start Date : March 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Indocyanine Green
Intravenous injection of 0.25 mg/kg Indocyanine Green in patients with peritoneal carcinomatosis from colorectal cancer before the surgery
Drug: Indocyanine Green
An iv injection will be performed for the colorectal cancer patient before the operation.
Other Name: ICG




Primary Outcome Measures :
  1. fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin. [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for "open" surgery,
  • Informed consent form signed.

Exclusion Criteria:

  • Age less than18 years old.
  • Inability to give informed consent.
  • History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  • Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomy of the thyroid gland.
  • Documented coronary disease.
  • Advanced renal impairment (creatinine > 1,5mg/dl).
  • During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  • Pregnancy, breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032485


Locations
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Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
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Principal Investigator: Gabriel Liberale, MD Surgeon in Jules Bordet Institute

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Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT02032485     History of Changes
Other Study ID Numbers: 2013-000653-42
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: July 2014
Keywords provided by Jules Bordet Institute:
colorectal cancer
Indocyanine Green
visualization of peritoneal metastases
Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinoma
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases