TerminatedPhase 2

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

Stopped: Clinical futility

Belgium14 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Rate of correct visualisation during debulking surgery with the near-infrared (NIR) fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.

Timeframe: During debulking surgery

Trial details

NCT IDNCT04891185

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Ovarian Cancer trials