CholecystitisPhase 2ICGNCT04942665
Low Dose ICG for Biliary Tract and Tumor Imaging
A Phase 2 study testing Indocyanine green and PINPOINT Endoscopic Fluorescence in people with Cholecystitis and Hepatocellular Carcinoma, run by University of Florida at 1 site in United States.
Trial summary
Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystitis, Hepatocellular Carcinoma, Liver Metastases
- What is being tested?
- Indocyanine green and PINPOINT Endoscopic Fluorescence
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 1 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing standard of care laparoscopic hepatic or biliary operations or Patients undergoing standard of care laparoscopic resection for hepatic tumors: hepatocellular carcinoma or metastatic tumor
Who cannot join
- Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes and Pregnant and/or lactating patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health Shands
Gainesville, Florida, 32610
About this study
Official title: Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
Read the detailed description
The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
The investigators intend to test our hypothesis with the following specific aims:
Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.
- Conditions
- Cholecystitis, Hepatocellular Carcinoma, Liver Metastases
- Being tested
- Indocyanine green, PINPOINT Endoscopic Fluorescence
- Keywords
- Biliary Tract, Indocyanine Green (ICG), Tumors, Near-infrared Fluorescence
- Medical subject headings
- Cholecystitis, Carcinoma, Hepatocellular, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called ICG
Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
PINPOINT Endoscopic FluorescenceDevice
Also called NIRF
The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | Prior to surgery these patients will be given a ICG dose of 0.05 mg IV. Receives: Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence |
| Standard Dose | Placebo comparator | Prior to surgery these patients will be given the ICG standard dose of 2.5 mg IV. Receives: Drug: Indocyanine green; Device: PINPOINT Endoscopic Fluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
Measured: intraoperative, average of 2 hours
Secondary outcomes (3)
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light
A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).
Measured: intraoperative, average of 2 hours
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the background fat
Measured: intraoperative, average of 2 hours
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
A qualitative assessment will be made based on the quality of the intraoperative visualization of the extrahepatic biliary tree on a scale of 1 to 5 (1 = no improvement/identification not confirmed; 2 = marginally improved; 3 = sufficiently improved; 4 = well improved; 5 = greatly improved/exceeds expectations).
Measured: intraoperative, average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start15 Sep 2021
- Primary completion15 Sep 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Society of University Surgeons
- Responsible party
- Sponsor
- Investigators
- Ali Zarrinpar, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942665
- Sponsor's protocol ID
- IRB202100388
- Other IDs
- OCR40380, PRO00043219
- Acronym
- ICG
- Status last verified
- Aug 2023
- First submitted
- 28 May 2021
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: We are not sharing individual participant data with other researchers
Publications
Ladd AD, Zarate Rodriguez J, Lewis D, Warren C, Duarte S, Loftus TJ, Nassour I, Soma D, Hughes SJ, Hammill CW, Zarrinpar A. Low vs Standard-Dose Indocyanine Green in the Identification of Biliary Anatomy Using Near-Infrared Fluorescence Imaging: A Multicenter Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):711-717. doi: 10.1097/XCS.0000000000000553. Epub 2023 Jan 10.
PubMed 36728303
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose ICG for Near-infrared Fluorescence Imaging of Biliary Tract and Tumors
- ClinicalTrials.gov ID
- NCT04942665
- Acronym / sponsor ID
- ICG / IRB202100388
- Conditions
- Cholecystitis, Hepatocellular Carcinoma, Liver Metastases
- Keywords
- Biliary Tract, Indocyanine Green (ICG), Tumors, Near-infrared Fluorescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Society of University Surgeons
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 30 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Near-infrared fluorescence (NIRF) imaging after an intravenous injection of indocyanine green (ICG) allows for the intraoperative identification of liver anatomy. The investigators have new data that a much lower dose improves this visualization. Confirmation of this hypothesis would mean that ICG can be administered on the same day of surgery in order to augment real-time intraoperative visualization, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
Detailed description
The investigators have a series of surgical cases in which the investigators have been able to achieve excellent intraoperative biliary visualization with a greatly decreased (50-200 fold lower) dose of ICG than the previously published dose. Furthermore, this decreased dose was visible in about 15-20 minutes from the time of injection with low liver background fluorescence, a significant improvement that would make its utilization in the operating room more practical. The investigators hypothesize that a lower dose will: 1) allow adequate visualization of the extrahepatic biliary tree, including the cystic, common hepatic, and common bile ducts. Confirmation of hypotheses would mean that a lower dose of ICG can be administered on the same day of surgery in order to augment real-time intraoperative localization of the extrahepatic biliary tree, thereby providing a safe, feasible, and cost-effective strategy for the surgical treatment of liver disease.
The investigators intend to test our hypothesis with the following specific aims:
Aim 1: To compare the efficacy and utility of a low dose ICG (0.05 mg) protocol with a previously published dose (2.5 mg) in imaging the extrahepatic biliary tract.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Adult patients scheduled to undergo a laparoscopic hepatic or biliary operation will be randomized to two groups 1) low dose (0.05 mg) or 2) standard dose (2.5 mg) of ICG preoperatively on the day of surgery. Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes will be excluded.
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Drug: Indocyanine green, Device: PINPOINT Endoscopic FluorescencePrior to surgery these patients will be given a ICG dose of 0.05 mg IV. |
| Standard Dose | Placebo comparator | Drug: Indocyanine green, Device: PINPOINT Endoscopic FluorescencePrior to surgery these patients will be given the ICG standard dose of 2.5 mg IV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing standard of care laparoscopic hepatic or biliary operations or Patients undergoing standard of care laparoscopic resection for hepatic tumors: hepatocellular carcinoma or metastatic tumor
Key exclusion criteria (1 listed)
- Patients with a history of adverse reactions or known allergy to ICG, iodine, or iodine dyes and Pregnant and/or lactating patients.
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 |
|---|---|---|
| Indocyanine greenAlso: ICGLow dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety). | Drug | Low Dose, Standard Dose |
| PINPOINT Endoscopic FluorescenceAlso: NIRFThe PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging. | Device | Low Dose, Standard Dose |
Primary outcome
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio
Time frame: intraoperative, average of 2 hours
Measurement is performed by dividing the fluorescence intensity signal of the common bile duct by that of the liver
3 secondary outcomes
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree - NIRFC Versus White Light
Time frame: intraoperative, average of 2 hours
Quantitative Assessment - Bile Duct-to-background Fat Fluorescence Intensity Ratio
Time frame: intraoperative, average of 2 hours
Qualitative Assessment of Overall Intraoperative Visualization of the Extrahepatic Biliary Tree (Common Hepatic Duct, Cystic Duct, Common Bile Duct, Aberrant Ducts)
Time frame: intraoperative, average of 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36728303Ladd AD, Zarate Rodriguez J, Lewis D, Warren C, Duarte S, Loftus TJ, Nassour I, Soma D, Hughes SJ, Hammill CW, Zarrinpar A. Low vs Standard-Dose Indocyanine Green in the Identification of Biliary Anatomy Using Near-Infrared Fluorescence Imaging: A Multicenter Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):711-717. doi: 10.1097/XCS.0000000000000553. Epub 2023 Jan 10.
- Individual participant dataSharing planned: No. We are not sharing individual participant data with other researchers
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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.
Ali Zarrinpar, MD, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine green and PINPOINT Endoscopic Fluorescence in people with Cholecystitis and Hepatocellular Carcinoma, run by University of Florida at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio (time frame: intraoperative, average of 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942665, which also lists 1 linked publication.
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 30 Aug 2023.