Near-Infrared Fluorescence Imaging for Gynecologic Surgery

Not currently recruiting at 7 trial locations

Overseen By Nadeem Abu-Rustum, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Hepatic dysfunction, Cirrhosis, Iodine allergy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special imaging technique, Near-Infrared Fluorescence Imaging with ICG (Indocyanine Green), can help doctors manage surgery more effectively for women undergoing pelvic or abdominal wall reconstruction. The goal is to determine if this imaging can improve intraoperative decisions and lead to better surgical site outcomes. Women who have had radical gynecologic surgery and are scheduled for reconstructive surgery at Memorial Sloan Kettering Cancer Center are suitable candidates for this trial. However, those with liver problems or allergies to iodine or ICG should not participate. As an unphased trial, this study offers participants the chance to contribute to innovative surgical advancements that could enhance future patient care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ICG-NIR angiography is safe for pelvic or abdominal wall reconstruction procedures?

Research has shown that indocyanine green (ICG) is generally safe for use in surgery. Surgeons use ICG fluorescence imaging during operations to guide them, and it has a strong safety record, having been tested and found safe in many situations. ICG can help reduce wound problems, especially in complex surgeries like abdominal wall repairs.

Studies have found that ICG, when used with near-infrared (NIR) imaging, is well-tolerated and can improve surgical outcomes. For example, it helps doctors see blood flow during surgery, which can lead to fewer complications. While any procedure carries risks, ICG has been used safely in various surgeries, demonstrating its reliable safety for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging techniques in reconstructive gynecologic surgery, which mainly rely on visual inspection and traditional imaging methods, ICG-NIR angiography offers a unique advantage. This technique uses near-infrared fluorescence imaging with indocyanine green (ICG) dye to provide real-time visualization of blood flow and tissue perfusion during surgery. Researchers are excited about this method because it can enhance the precision of surgical procedures, potentially improving outcomes by reducing complications related to insufficient blood supply. This innovation promises to elevate the safety and effectiveness of complex reconstructive surgeries.

What evidence suggests that ICG-NIR angiography is effective for altering intraoperative management of the flap or wound bed?

Research has shown that ICG-NIR angiography, which uses a special dye and near-infrared light, guides surgeries by revealing blood flow. In one study, it altered the surgical plan in half of the cases, indicating it aids surgeons in making better decisions. During colon and rectum surgeries, it improved blood flow assessments, crucial for healing. Another study highlighted its potential in breast reconstruction, though concerns about its reliability remain. Overall, evidence suggests this method could reduce complications during reconstructive surgeries. Participants in this trial will undergo pelvic or abdominal wall reconstruction procedures using ICG-NIR angiography to potentially enhance surgical outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Nadeem Abu-Rustum, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo pelvic or abdominal wall reconstruction with intraoperative ICG-NIR angiography to assess flap perfusion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ICG-NIR angiography

How Is the Trial Designed?

Group I: Participants undergoing a pelvic or abdominal wall reconstruction procedure Experimental Treatment 1 Intervention

Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10277941/

Application of indocyanine green in surgery: A review ... We conducted a narrative review to address the utility of ICG in the surgical management of patients with trauma as well as elective surgery. This will guide ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/14/5/e079858

Perfusion outcomes with near-infrared indocyanine green ... A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial.

3. abs.amegroups.org abs.amegroups.org/article/view/8652/html

Indocyanine green angiography—current status on ... Conclusions: ICG-FA appears promising in accessing perfusion in breast reconstruction procedures. However, concerns persist regarding the reliability of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10705733/

NIR ICG-Enhanced Fluorescence: A Quantitative Evaluation of ... The aim of this study was to evaluate the timing of fluorescence as a reproducible parameter and its efficacy in predicting anastomotic leakage ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962647/

Update on near infrared imaging technology: indocyanine ... Investigators found that NIR angiography altered intraoperative management in 50% of patients, meeting the primary endpoint of this study. Wound complications ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24013276

Update on near infrared imaging technology: indocyanine ... The objective of the current review is to present recent advances in the use of near-infrared (NIR) imaging with indocyanine green (ICG) specific to ureter ...

7. fvvo.eu fvvo.eu/articles/improving-efficacy-and-safety-of-surgery-in-benign-gynaecology-the-case-for-indocyanine-green/FVVO.2025.94

Improving efficacy and safety of surgery in benign ... Indocyanine green (ICG) is a versatile compound with a well-established safety profile and growing applications in minimally invasive surgery, ...

8. sages.org sages.org/meetings/annual-meeting/abstracts-archive/outcomes-using-indocyanine-green-angiography-with-perforator-sparing-component-separation-technique-for-abdominal-wall-reconstruction/

Outcomes Using Indocyanine Green Angiography with ... Conclusions: Intraoperative ICG can help decrease overall costs associated with complex ventral hernia repairs by decreasing wound complication rates.