Hepatobiliary SurgeryNCT03946761
Fluorescence Imaging in Hepatobiliary Surgery
A study testing Cancer goggle system in people with Hepatobiliary Surgery, run by Washington University School of Medicine.
Trial summary
A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatobiliary Surgery
- What is being tested?
- Cancer goggle system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned open liver resection or ablation.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- -History of allergic reactions attributed to ICG, iodine, iodine dye, or other agents used in the study.
About this study
Official title: Evaluation of Fluorescence Imaging in Hepatobiliary Surgery
A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.
- Conditions
- Hepatobiliary Surgery
- Being tested
- Cancer goggle system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer goggle systemDevice
-The cancer goggle system is being used as a non-significant risk device
| Study group | Role | What they receive |
|---|---|---|
| Cancer goggle system | Experimental | * The surgical procedure will be performed according to standard practice, with the exception of microdosing of ICG \& visualization of biliary/liver anatomy using the cancer goggles system
* The surgeon will start with a peripherally injected microdose of 0.02 mg of ICG \& will inject an additional 0.02mg every 5 minutes until a noticeable fluorescent change in the liver is observed. If a change is not observed after 0.14 mg has been injected then the microdosing regimen will stop. Output video from the cancer goggles will be recorded and saved for post-surgical analysis.
* Following resection of the liver parenchyma, the portal area and the cut surface of the liver will be analyzed for the identification of bile ducts leaks with or without cancer goggles. Receives: Device: Cancer goggle system |
What is being measured
The primary outcome is the main question the study is designed to answer.
The minimum dose of the ICG that causes initial fluorescence of the liver
Measured: Through completion of surgery for all participants enrolled (estimated to take 1 year)
Secondary outcomes (1)
The visible status of the bile ducts and/or bile leaks from the cut surface of the liver at ICG doses administered in our dosing regimen
Measured: Through completion of surgery for all participants enrolled (estimated to take 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: One of the main investigators is leaving the University.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chet Hammill, M.D., FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946761
- Sponsor's protocol ID
- 201904180
- Status last verified
- Jan 2022
- First submitted
- 30 Apr 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluorescence Imaging in Hepatobiliary Surgery
- ClinicalTrials.gov ID
- NCT03946761
- Acronym / sponsor ID
- 201904180
- Conditions
- Hepatobiliary Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: One of the main investigators is leaving the University.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A current gap in the use indocyanine green fluorescence to isolate the biliary system is the dosing amount necessary to fluoresce the biliary system without "over" fluorescing the liver and gallbladder. Over fluorescing surrounding structures such as the liver and gallbladder saturates the image and makes it impossible to identify biliary leaks or differentiate branches of the common bile duct using fluorescent imaging devices. The over dosing does not affect the standard of care procedure, but eliminates the added benefit of the fluorescent imaging technology. The use of "microdoses" (approximately 0.1 mg) of indocyanine green has been trialed and shown promise in some patients. This study aims to do an in depth study utilizing the Cancer goggle systems fluorescent imaging system to determine the correct dose needed to isolate the biliary system without over fluorescing surrounding structures. This dosing study could additionally serve as a pilot study for follow on research using indocyanine green and fluorescent imaging in hepatobiliary surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer goggle system | Experimental | Device: Cancer goggle system* The surgical procedure will be performed according to standard practice, with the exception of microdosing of ICG \& visualization of biliary/liver anatomy using the cancer goggles system * The surgeon will start with a peripherally injected microdose of 0.02 mg of ICG \& will inject an additional 0.02mg every 5 minutes until a noticeable fluorescent change in the liver is observed. If a change is not observed after 0.14 mg has been injected then the microdosing regimen will stop. Output video from the cancer goggles will be recorded and saved for post-surgical analysis. * Following resection of the liver parenchyma, the portal area and the cut surface of the liver will be analyzed for the identification of bile ducts leaks with or without cancer goggles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned open liver resection or ablation.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Key exclusion criteria (1 listed)
- -History of allergic reactions attributed to ICG, iodine, iodine dye, or other agents used in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer goggle system-The cancer goggle system is being used as a non-significant risk device | Device | Cancer goggle system |
Primary outcome
The minimum dose of the ICG that causes initial fluorescence of the liver
Time frame: Through completion of surgery for all participants enrolled (estimated to take 1 year)
1 secondary outcome
The visible status of the bile ducts and/or bile leaks from the cut surface of the liver at ICG doses administered in our dosing regimen
Time frame: Through completion of surgery for all participants enrolled (estimated to take 1 year)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chet Hammill, M.D., FACS principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Cancer goggle system in people with Hepatobiliary Surgery, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The minimum dose of the ICG that causes initial fluorescence of the liver (time frame: Through completion of surgery for all participants enrolled (estimated to take 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.