In breve
Clinical trials are studying Indocyanine Green in different surgical settings, such as cancer surgery, gallbladder surgery, thyroid surgery, and lymph node mapping. These studies look at how well it helps surgeons see tissues better, and they also measure safety, accuracy, and surgical outcomes. The trials include adults and, in some studies, children with specific conditions.
Punti chiave
- Clinical trials with Indocyanine Green are studying many surgery-related uses, especially in cancer care. The main goals are to help surgeons see lymph nodes, tumor margins, bile ducts, blood flow, and important glands more clearly. Most studies are Phase 2 or Phase 3, with one Phase 1/2 study and one Phase 4 study, and they include both adults and children. The conditions studied include breast, ovarian, cervical, colorectal, liver, thyroid, head and neck, gynecologic, and pediatric tumors, plus gallbladder disease and acute cholecystitis. Several trials also measure surgical time, complications, and how accurately the technique identifies disease or healthy tissue. Overall, the research is focused on making surgery safer and more precise.
Overview of the trial program
The trial data show many different uses of Indocyanine Green in surgery and imaging. Most studies are trying to see whether it helps surgeons find important structures more clearly, such as lymph nodes, bile ducts, tumor margins, blood vessels, or glands.
The studies include people with cancer, people having gallbladder or thyroid surgery, and some other specific patient groups such as people with lipedema or uveitis. The trials are mostly interventional studies, which means the researchers give a planned procedure or imaging approach and measure the results.
Cancer surgery studies
Several trials focus on sentinel lymph node mapping, which is a way to find the first lymph node or nodes that may receive cancer spread. One Phase 2 study includes patients with melanoma of the head or neck or upper trunk, oral malignancies, or penile carcinoma, and it compares ICG-based hybrid tracing with another tracer method during sentinel node biopsy.
In ovarian cancer, a Phase 3 trial is testing the sentinel lymph node technique in early-stage disease and measuring the negative predictive value, which means how well a negative result truly rules out lymph node metastases. Another Phase 3 trial in cervical cancer stage I-IIA compares bilateral sentinel node detection with fluorescent Indocyanine Green versus standard methods using technetium and blue dye.
Breast cancer is also studied in two different ways. One Phase 2 trial in early invasive breast cancer looks at the accuracy of ICG fluorescence imaging for detecting positive surgical margins, while another small Phase 2 study checks whether fluorescence remains visible in axillary lymph nodes weeks after injection in patients with metastatic lymph nodes.
Liver surgery is another major area of research. A Phase 3 study in patients with liver tumors undergoing minimally invasive surgery is testing whether preoperative Indocyanine Green improves intraoperative tumor detection, and it also aims to develop a machine-learning method to detect tumors from photographic images.
Head and neck surgery is studied in a Phase 2 trial that uses near-infrared imaging with Indocyanine Green to find microscopic residual disease after tumor removal. Colorectal cancer is the focus of a large low-intervention study testing whether fluorescence angiography with Indocyanine Green can reduce anastomotic leakage after bowel surgery.
Other cancer trials study solid tumors of the digestive system, gynecological cancers during pelvic exenteration, and pediatric solid tumors such as rhabdomyosarcoma, neuroblastoma, malignant germ cell tumors, and renal tumors. These studies mainly look at whether fluorescence helps with tumor visualization, margin assessment, or lymph node harvest.
Non-cancer surgery studies
Some trials are not centered on cancer, but on improving surgical safety and planning. In symptomatic gallstones, one Phase 3 study compares different doses and timing of Indocyanine Green during laparoscopic cholecystectomy to improve the view of biliary structures.
Another Phase 3 trial in urgent surgery for acute cholecystitis studies whether preoperative Indocyanine Green can shorten surgical time and help identify the extrahepatic bile duct. In thyroid surgery, two Phase 3 studies examine whether Indocyanine Green angiography helps preserve the parathyroid glands and reduce problems such as hypoparathyroidism and hypocalcemia.
A Phase 3 feasibility study after total laparoscopic hysterectomy looks at the vascularization of the vaginal cuff, also called the vaginal slice, by measuring fluorescence over time. Another Phase 2 pilot study in pelvic exenteration for recurrent or persistent gynecological cancer checks vascularity of the ileal conduit and ureteral resection margins, with the goal of reducing benign uretero-enteric strictures.
There is also a Phase 3 study in lipedema, which compares women with lipedema and healthy subjects to see whether ICG lymph-fluoroscopy can be a useful diagnostic tool for superficial lymphatic vessels. A Phase 2 study in uveitis includes patients with recently active non-infectious intermediate, posterior, and pan-uveitis, and Indocyanine Green is part of the eye imaging procedures used in the trial.
Phases, participants, and endpoints
The trials range from Phase 1/2 to Phase 4, with many in Phase 2 or Phase 3. This means the program includes both early studies that explore safety and dose, and larger studies that test whether the method improves surgical results.
Enrollment varies widely, from very small studies with 10 or 29 participants to large studies with more than 1,000 participants. This shows that some trials are pilot studies, while others are broad comparisons of surgical techniques in many patients.
The most common endpoints are about visibility and accuracy. Examples include sentinel node detection, identification of biliary structures, detection of liver tumors, finding microscopic residual disease, measuring tumor-to-background ratio, and checking whether surgical margins are clear.
Some studies also measure clinical outcomes such as surgical time, anastomotic leakage, hypocalcemia, hypoparathyroidism, and benign uretero-enteric stricture. In simple terms, these endpoints ask whether the imaging method helps surgeons work more safely and whether it reduces complications after surgery.
What these studies may mean for patients
For patients, these trials are mainly about making surgery more precise. The research asks whether Indocyanine Green can help surgeons see the right tissue at the right time, which may support better decisions during an operation.
Because the studies cover many different diseases, the people who can join are very specific to each trial. A person may qualify only if they have a certain cancer type, a certain stage of disease, or are scheduled for a specific surgery such as sentinel node biopsy, cholecystectomy, thyroidectomy, or breast-conserving surgery.
Some trials are already completed, while others are authorised and still ongoing. Together, they show that Indocyanine Green is being studied mainly as a tool for surgical imaging and guidance across many specialties.