Clinical trial NCT04891185: Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
Official title: Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Rate of diagnostic accuracy during debulking surgery with the NIR fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.
timeFrame: During debulking surgery
measure: Percentage of lesions with positive correlation between pre-operative radiographic examination(s) and the ICG signal in vivo with the NIR fluorescence camera during surgery and immediately after surgery with the pathological examination.
timeFrame: During debulking surgery and immediately after debulking surgery, when the pathological examination report is available.
measure: Obtaining the tumour-to-background ratio of fluorescence in peritoneal lesions, lymph nodes and other anatomical structures during debulking surgery by utilising still images captures with the NIR fluorescence camera.
timeFrame: During debulking surgery
measure: Assessment of the number and type of adverse effects, severe adverse effects and adverse reactions with the trial dose of the IMP during and immediately after the surgery.
timeFrame: During debulking surgery and immediately after the surgery, up to the point in time when the pathological report is available.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
References: