Indocyanine Green for Pancreatic Cancer

Overseen By Gustavo Salgado-Garza, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Contrast dye allergy, Prior pancreatectomy, Hepatic insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special dye called indocyanine green to determine its effectiveness in predicting leaks after pancreas surgery. It targets individuals scheduled for specific pancreas surgeries, such as pancreaticoduodenectomy or distal pancreatectomy, who do not require major artery repairs. Participants should not have liver issues or a history of dye allergies. The aim is for this dye to enhance surgical safety by identifying problems early. As a Phase 2 trial, it measures the dye's effectiveness in an initial, smaller group, allowing participants to contribute to important research that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that indocyanine green is safe for predicting postoperative pancreatic leaks?

Research has shown that indocyanine green (ICG) is generally safe for people. The FDA has approved it for specific uses, such as aiding doctors in visualizing blood flow during surgeries, indicating it has passed safety tests for those purposes. Studies have found that ICG can be safely used in various surgeries, including those involving blood vessels and organs. However, monitoring its use remains important to ensure safety. Some studies suggest vigilance for any rare side effects when using ICG. Overall, evidence indicates that ICG is well-tolerated in approved situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using indocyanine green (ICG) in pancreas surgery because it offers a unique way to enhance the precision of surgical procedures. Unlike traditional surgical techniques that rely heavily on the surgeon’s visual assessment, ICG is administered intravenously and allows for real-time imaging of blood flow and tissue perfusion during the operation. This can lead to more accurate identification of critical structures and potentially reduce complications. The ability to visualize these aspects with clarity could improve surgical outcomes, making it a promising advancement in pancreatic surgery.

What evidence suggests that indocyanine green is effective for predicting postoperative pancreatic leaks?

Research has shown that indocyanine green (ICG) improves surgical outcomes. Studies have found that ICG enhances surgical efficiency and provides clearer visibility for doctors during operations. It also reduces the need to switch from less invasive to open surgery and shortens hospital stays. One study found that using ICG in surgeries lowered the risk of complications, such as leaks, after the operation. This makes it a promising tool for predicting and preventing problems during pancreas surgery. Participants in this trial will receive indocyanine green intravenously during surgery, undergo imaging, and have their medical records reviewed as part of the observational study. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick J Worth

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

You comprehend the scope and implications of clinical trials.

Participants of childbearing potential must present a negative pregnancy test and use adequate contraception until two weeks following the trial intervention.

A closed suction drain must be installed post-procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Patients receive indocyanine green intravenously during surgery and undergo imaging

During surgical intervention (hours)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of leak grades and perfusion metrics

Up to 30 days after surgery

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

How Is the Trial Designed?

Group I: Observational Experimental Treatment 1 Intervention

Patients receive indocyanine green IV during surgery, undergo imaging and have their medical records reviewed on study.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11834857/

Narrative Review on the Use of Indocyanine Green ... This narrative review aims to synthesize findings from a comprehensive range of studies that evaluate the efficacy, applications and limitations of ICG ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1572100025007768

A meta-analysis of the efficacy and safety of indocyanine ... Fluorescence imaging enhances surgical efficiency, reduces the risk of conversion to open surgery, and shortens hospital stay. Its safety and ...

3. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-025-04334-1

5-year outcomes from the FUGES-012 randomized clinical trial ICG fluorescence imaging-guided lymphadenectomy not only significantly improved the 5-year OS and DFS but also noticeably reduced the recurrence ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e16115

Effect of fluorescent imaging using indocyanine green on ... The aim of this study was to determine the impact of ICG during minimally invasive esophagectomy (MIE) in reducing the rates of anastomotic failure.

5. nature.com nature.com/articles/s41598-025-97912-5

Comparative analysis of indocyanine green dosages for ... This study aimed to investigate the efficacy of different doses of Indocyanine Green (ICG) for fluorescence imaging during laparoscopic cholecystectomy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10989327/

Indocyanine green: The guide to safer and more effective ... Indocyanine green, used for fluorescence imaging, has been approved by the Food and Drug Administration and is safe for use in humans. It can be administered ...

7. nature.com nature.com/articles/s41598-024-81903-z

Diagnostic Dyes: Indocyanine Green Adverse Reactions This study provides valuable insights into the safety profile of ICG, highlighting the need for further monitoring to ensure its safe clinical ...

8. fda.gov fda.gov/files/drugs/published/383_211580%20indocyanine%20green%20unireview%20prea.pdf

211580Orig1s000 SPY AGENT Green is indicated for fluorescence imaging of blood flow and tissue perfusion during: vascular, gastrointestinal, organ transplant, ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.917541/full

Safety and efficacy of indocyanine green near-infrared ... This meta-analysis showed that ICG near-infrared fluorescent imaging-guided gastrectomy is safe and effective. Nevertheless, high-quality studies with long-term ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0022346822007114

Safety and Feasibility of Indocyanine Green Fluorescence ... This systematic review analyzes whether ICG is useful for intestinal perfusion assessment in pediatric gastrointestinal surgery and safe to use in neonates.