Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients

Ovarian Cancer Clinical Trial

— OV-AP-ICG-IV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834469
• Other study ID #: 2083
• Secondary ID: 2013-000276-15
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 14, 2013
• Last updated: October 14, 2014
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2014
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Carcinomatosis

Intervention

Drug:
• iv injection of ICG
An iv injection will be performed for the ovarian cancer patient before the operation.

Locations

Country	Name	City	State
Belgium	Jules Bordet Institute	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from ovarian carcinoma	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.	1 year	No