Feasibility study of the (intravenously injected) Indocyanine green (ICG) imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000276-15-BE

Enrollment

Registered

2013-02-15

Start date

2013-03-08

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Peritoneal carcinomatosis from ovarian 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 histo-pathological diagnosis of ovarian carcinoma and peritoneal carcinomatosis 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 autonomies of the thyroid gland. - Documented coronary disease. - Advanced renal impairment (creatinine > 1,5mg/dl).

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the ability of NIR imaging to image and to detect the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG the day before surgery. ;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 pre-operatively, in the nodes of these patients found fluorescent and removed).;Primary end point(s): Evaluation of the ability of NIR imaging to image and to detect the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG the day before surgery. ;Timepoint(s) of evaluation of this end point: End of the study.	—

Measure

Time frame

Main Objective: Evaluation of the ability of NIR imaging to image and to detect the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG the day before surgery. ;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 pre-operatively, in the nodes of these patients found fluorescent and removed).;Primary end point(s): Evaluation of the ability of NIR imaging to image and to detect the « viable » gross tumoral mass and/or peritoneal metastatic « implants » in women operated for ovarian carcinoma with peritoneal carcinomatosis after the IV injection of ICG the day before surgery. ;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 pre-operatively, in the nodes of these patients found fluorescent and removed).;Timepoint(s) of evaluation of this end point: End of the study.	—

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