Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients
Condition: Ovarian Cancer; Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Peritoneal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if NIF fluorescent imaging is an effective approach
      to detect the gross ovarian tumoral tissues and peritoneal implants in Ovarian cancer
      patients.
    

Detailed description: 
      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.
    

Intervention name(s): iv injection of ICG
Intervention type(s): Drug
Intervention description(s): An iv injection will be performed for the ovarian cancer patient before the operation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ovarian,metastasis