Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer

NCT ID: NCT04891185

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-10-01

Brief Summary

Visualise peritoneal lesions of epithelial ovarian cancer (EOC) in both primary and interval debulking surgery by using intravascular indocyanine green (ICG) and near-infrared (NIR) light. This Trial wants to investigate whether ICG can increase the visibility of peritoneal lesions and can differentiate between peritoneal implants and fibrosis.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Primary Debulking Surgery

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: DRUG

Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection

Interval Debulking Surgery

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: DRUG

Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection

Interventions

Indocyanine green

Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.

2. At least 18 years of age.

3. Advanced stage epithelial ovarian cancer: FIGO stage IIIb, IIIc or IV. (For FIGO staging classification, please refer to Appendix 7).

4. A biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma

5. Preoperative imaging (CT and/or MRI), describing metastatic implants, as standard of care.

Exclusion Criteria

1. Participant has a history of following diseases:

1. Hyperthyroidism

2. Autonomously functioning thyroid adenoma

2. Participant has an allergy or hypersensitivity for one or more of the following components:

1. Iodine (including potassium iodine)

2. Indocyanine green

3. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.

4. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.

5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.

6. Participant has a severe renal impairment (classified as renal function<30 ml/min/1,73m2 according to CKD-EPI).

7. Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:

1. Danaparoid (Orgaran®)

2. Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion.

8. Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.

9. A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.

10. Participants utilises one of the interacting drugs listed in the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

2021-002449-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S65525

Identifier Type: -

Identifier Source: org_study_id