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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Terminated; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT04891185

S65525

2021-002449-13 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Primary Debulking Surgery

Experimental group

Treatment:

Drug: Indocyanine green

Interval Debulking Surgery

Experimental group

Treatment:

Drug: Indocyanine green