Near Ifrared imaging of peritoneal metastasis of colon cancer origine.

Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000653-42-BE

Enrollment

Registered

2013-02-27

Start date

2013-03-20

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal carcinomatosis from colon Cancer.

Interventions

Trade Name: ICG Pulsion Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: INDOCYANINE GREEN CAS Number: 3599-32-4 Current Sponsor code: pulsion-001 Other descriptive name: IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for “open” surgery, either after neo-adjuvant chemotherapy (80-90% of the cases), or in “first intent”. - Informed consent form signed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 dissemi-nated 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the ability of NIR imaging using ICG to demonstrate the « viable » 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, in the nodes of these patients found fluorescent and removed and/or at the level of the fluorescent foci observed at the level of the hepatic surfaces);Primary end point(s): Evaluation of the ability of NIR imaging using ICG to demonstrate the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in patients operated for peritoneal carcinomatosis from colorectal carcinoma ;Timepoint(s) of evaluation of this end point: End of the study.	—

Measure

Time frame

Main Objective: Evaluation of the ability of NIR imaging using ICG to demonstrate the « viable » 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, in the nodes of these patients found fluorescent and removed and/or at the level of the fluorescent foci observed at the level of the hepatic surfaces);Primary end point(s): Evaluation of the ability of NIR imaging using ICG to demonstrate the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in patients operated for peritoneal carcinomatosis from colorectal carcinoma ;Timepoint(s) of evaluation of this end point: End of the study.

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Secondary

Measure	Time frame
Secondary end point(s): 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, in the nodes of these patients found fluorescent and removed and/or at the level of the fluorescent foci observed at the level of the hepatic surfaces);Timepoint(s) of evaluation of this end point: End of the study.	—

Measure

Time frame

Secondary end point(s): 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, in the nodes of these patients found fluorescent and removed and/or at the level of the fluorescent foci observed at the level of the hepatic surfaces);Timepoint(s) of evaluation of this end point: End of the study.

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Countries

Belgium

Contacts

Public ContactProf. Bourgeois

Jules Bordet Institute

pierre.bourgeois@bordet.be003225413276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026