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
histopathology.

- 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
future.

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.

Methodology:

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.