Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients

NCT ID: NCT01834469

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-10-31

Brief 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.

Conditions

Ovarian Cancer; Peritoneal Carcinomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ICG NIR imaging

see Summary and description iv injection of ICG

Group Type: OTHER

iv injection of ICG

Intervention Type: DRUG

An iv injection will be performed for the ovarian cancer patient before the operation.

Interventions

iv injection of ICG

An iv injection will be performed for the ovarian cancer patient before the operation.

Intervention Type: DRUG

Eligibility 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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Veys, MD

Role: PRINCIPAL_INVESTIGATOR

Surgeon in Jules Bordet Institute

Gabriel Liberale, MD

Role: STUDY_CHAIR

Surgeon in Jules Bordet Institute

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

Other Identifiers

2013-000276-15

Identifier Type: OTHER

Identifier Source: secondary_id

2083

Identifier Type: -

Identifier Source: org_study_id