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

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Drug: Indocyanine green

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Debulking Surgery	Drug: Indocyanine green; Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection
Experimental: Interval Debulking Surgery	Drug: Indocyanine green; Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of diagnostic accuracy during debulking surgery with the NIR fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.	During debulking surgery
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.	During debulking surgery and immediately after debulking surgery, when the pathological examination report is available.
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.	During debulking surgery
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.	During debulking surgery and immediately after the surgery, up to the point in time when the pathological report is available.

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: S65525; 2021-002449-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: According to FAIR principle will data sharing be possible after conclusion of this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No