A Phase 2 interventional study of Indocyanine Green in Colorectal Cancer and Peritoneal Carcinomatosis, sponsored by Jules Bordet Institute. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by Jules Bordet Institute · Phase 2, Interventional, and Diagnostic
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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.
Also known as: ICG
fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.
Time frame: 1 week
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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