Status:
TERMINATED
Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- At least 18 years of age.
- Advanced stage epithelial ovarian cancer: FIGO stage IIIb, IIIc or IV. (For FIGO staging classification, please refer to Appendix 7).
- A biopsy or cytology confirming the presence of high-grade serous epithelial ovarian carcinoma
- Preoperative imaging (CT and/or MRI), describing metastatic implants, as standard of care.
Exclusion
- Participant has a history of following diseases:
- Hyperthyroidism
- Autonomously functioning thyroid adenoma
- Participant has an allergy or hypersensitivity for one or more of the following components:
- Iodine (including potassium iodine)
- Indocyanine green
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.
- Participant has a severe renal impairment (classified as renal function\<30 ml/min/1,73m2 according to CKD-EPI).
- Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:
- Danaparoid (Orgaran®)
- Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion.
- Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.
- A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.
- Participants utilises one of the interacting drugs listed in the protocol
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04891185
Start Date
October 1 2021
End Date
October 1 2023
Last Update
October 5 2023
Active Locations (1)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000