Imaging of Peritoneal Carcinomatosis From Ovarian Carcinoma Patients

NCT01834469 | Completed Phase 1 DMC

• 2 other identifiers: 20832013-000276-15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Peritoneal Carcinomatosis

Keywords

Ovarian,metastasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ICG NIR imaging

OTHER

see Summary and description iv injection of ICG

Drug: iv injection of ICG

Interventions

iv injection of ICG DRUG

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

ICG NIR imaging

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institute

Brussels, B-1000, Belgium

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Peritoneal Neoplasms; Krukenberg Tumor

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Carcinoma, Signet Ring Cell; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Isabelle Veys, MD

  Surgeon in Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

• Gabriel Liberale, MD

  Surgeon in Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 18, 2013
• Study Start: March 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-07

Locations

BE (1)