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

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; Advanced stage high-grade serous epithelial ovarian cancer: FIGO stage IIIb, IIIc and IV

• Registration Number: EUCTR2021-002449-13-BE
• Lead Sponsor: niversity Hospitals Leuven (UZ Leuven)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Participant has a history of following diseases:
a.Hyperthyroidism
b.Autonomously functioning thyroid adenoma
2.Participant has an allergy or hypersensitivity for one or more of the following components:
a.Iodine (including potassium iodine)
b.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 eGFR<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:
a.Danaparoïde (Orgaran®)
b.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified