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

NCT04891185 | Terminated Phase 2

• 2 other identifiers: S655252021-002449-13
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (2)

Primary Debulking Surgery

EXPERIMENTAL

Drug: Indocyanine green

Interval Debulking Surgery

EXPERIMENTAL

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection

Interval Debulking Surgery; Primary Debulking Surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biologically female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device during the surgery itself.
• Participant has a severe renal impairment (classified as renal function\<30 ml/min/1,73m2 according to CKD-EPI).
• Participant utilises sodium bisulfite-containing heparin preparations during the day before surgery. For Belgian registered drugs, this contains:
• Danaparoid (Orgaran®)
• Participants requires thyroid scintigraphy utilising radioactive iodine one week after surgery.
• A previous history of major intra-abdominal surgery with potentially major adhesions and/or distorted anatomy.
• Participants utilises one of the interacting drugs listed in the protocol

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 18, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-05

Locations

BE (1)