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Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Carcinomatosis

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Trial Information

Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma

Primary 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 ( which is approved for human use)
the day before the operation.

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).

however other goals of our project will be will be:

- to confirm that all dissected fluorescent tissue samples are malignant by

- to study the histological distribution of ICG in these tumoral tissues.

- to investigate if there is any other florescent tissue in the peritoneal areas which
surgeons could not detect any visible tumor implants.

- to distinguish by ICG distribution in between viable tumor tissue from fibrosis and
necrosis caused by chemotherapy which is normally difficult to be defined in scars
which are routinely removed, but if we could identify the viable tumor tissue by NIF
imaging in the operation room, surgeons can avoid dissecting benign scars in the

Hopefully ICG will be able to help, firstly, in the scoring of the peritoneal cancer index
(PCI) enhancing the detection of small nodules which were undetected by normal visualization
allowing a more 'complete' surgical treatment of the disease and secondarily, in the staging
of these patients with the potential to upgrade patients from stage I/II to stage III in
cases where fluoroscopy would allow to detect unknown minimal peritoneal carcinomatosis.


The day before the operation:

ICG 0.25 mg/kg will be given as an iv injection the day before the operation.

In the operating room:

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

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 lymph nodes were suspected to be metastatic (for instance on the basis of the PET-CT with
18F-DG performed before surgery), they will be searched, (optionally controlled in vivo for
their visibility using NIR camera)and dissected.

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.

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 autonomies of the thyroid gland.

- Documented coronary disease.

- Advanced renal impairment (creatinine > 1,5mg/dl).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

Evaluation of the feasibility of NIF imaging to detect tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma, the efficacy of this approach will be confirmed by histological test of the dissected tissue.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Isabelle Veys, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

March 2013

Completion Date:

March 2014

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Carcinomatosis
  • Ovarian,metastasis
  • Carcinoma
  • Ovarian Neoplasms