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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Universitaire Ziekenhuizen Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary Debulking Surgery

Interval Debulking Surgery

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of diagnostic accuracy during debulking surgery with the NIR fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.
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.
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.
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.

Full Information

First Posted
May 5, 2021
Last Updated
October 2, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04891185
Brief Title
Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
Acronym
VIPIDO
Official Title
Visualisation of Indocyanine Green in Primary and Interval Debulking for Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Clinical futility
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Debulking Surgery
Arm Type
Experimental
Arm Title
Interval Debulking Surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Description
Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection
Primary Outcome Measure Information:
Title
Rate of correct visualisation during debulking surgery with the near-infrared (NIR) fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.
Time Frame
During debulking surgery
Secondary Outcome Measure Information:
Title
Rate of diagnostic accuracy during debulking surgery with the NIR fluorescence camera of peritoneal lesions of EOC in vivo by utilising ICG.
Time Frame
During debulking surgery
Title
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.
Time Frame
During debulking surgery and immediately after debulking surgery, when the pathological examination report is available.
Title
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.
Time Frame
During debulking surgery
Title
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.
Time Frame
During debulking surgery and immediately after the surgery, up to the point in time when the pathological report is available.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biologically female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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®) Other low-molecular weight heparins registered in Belgium do not contain sodium bisulfite and are not an exclusion criterion. 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
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
According to FAIR principle will data sharing be possible after conclusion of this trial.

Learn more about this trial

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

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