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Indocyanine Green

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.

Table of contents

Overview of the trial program

The trial data show many different uses of Indocyanine Green in surgery and imaging.[1] 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.[1]

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.[1] The trials are mostly interventional studies, which means the researchers give a planned procedure or imaging approach and measure the results.[1]

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.[1] 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.[1]

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.[1] 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.[1]

Breast cancer is also studied in two different ways.[1] 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.[1]

Liver surgery is another major area of research.[1] 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.[1]

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.[1] 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.[1]

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.[1] These studies mainly look at whether fluorescence helps with tumor visualization, margin assessment, or lymph node harvest.[1]

Non-cancer surgery studies

Some trials are not centered on cancer, but on improving surgical safety and planning.[1] 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.[1]

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.[1] 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.[1]

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.[1] 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.[1]

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.[1] 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.[1]

Phases, participants, and endpoints

The trials range from Phase 1/2 to Phase 4, with many in Phase 2 or Phase 3.[1] This means the program includes both early studies that explore safety and dose, and larger studies that test whether the method improves surgical results.[1]

Enrollment varies widely, from very small studies with 10 or 29 participants to large studies with more than 1,000 participants.[1] This shows that some trials are pilot studies, while others are broad comparisons of surgical techniques in many patients.[1]

The most common endpoints are about visibility and accuracy.[1] 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.[1]

Some studies also measure clinical outcomes such as surgical time, anastomotic leakage, hypocalcemia, hypoparathyroidism, and benign uretero-enteric stricture.[1] In simple terms, these endpoints ask whether the imaging method helps surgeons work more safely and whether it reduces complications after surgery.[1]

What these studies may mean for patients

For patients, these trials are mainly about making surgery more precise.[1] 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.[1]

Because the studies cover many different diseases, the people who can join are very specific to each trial.[1] 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.[1]

Some trials are already completed, while others are authorised and still ongoing.[1] Together, they show that Indocyanine Green is being studied mainly as a tool for surgical imaging and guidance across many specialties.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT06666634Phase 2Melanoma, oral malignancies, penile carcinomaAuthorised29
2025-522535-33-00Phase 3Symptomatic cholelithiasisAuthorised122
2023-508316-27-00Phase 3Liver tumorsAuthorised173
NCT06963268Phase 3Ovarian cancerAuthorised200
2025-521273-14-00Phase 1/2Solid neoplasms of the digestive systemAuthorised44
2024-518677-34-00Phase 3Acute cholecystitisAuthorised440
2023-509130-18-00Phase 3Hypothyroidism / thyroid surgeryAuthorised394
2024-511966-36-00Low InterventionCervical cancer stage I-IIACompleted101
2022-502737-26-00Phase 2Epidermoid carcinomaAuthorised65
2023-504024-26-00Phase 2Early invasive breast cancerAuthorised250
2024-516255-41-00Phase 3Thyroid diseases, hypoparathyroidism, hypocalcemiaAuthorised242
NCT05168839Low InterventionColorectal cancerAuthorised1010
2024-514089-37-00Phase 2Pediatric oncology surgeryAuthorised290
NCT06347354Phase 2Breast cancerAuthorised10
2024-518783-13-00Phase 2Gynecological cancers undergoing pelvic exenterationAuthorised40

FAQ

  • What are clinical trials with Indocyanine Green trying to find out? They are testing whether Indocyanine Green helps surgeons see blood vessels, bile ducts, lymph nodes, tumor margins, or other tissues more clearly. Many studies also check if it improves surgical accuracy or lowers complications.
  • Who can take part in these studies? It depends on the trial. The studies include people with cancers such as breast, ovarian, cervical, colorectal, liver, thyroid, head and neck, and pediatric solid tumors, as well as people having gallbladder surgery or hysterectomy.
  • What phases are these trials in? The trials range from Phase 1/2 to Phase 4, and some are marked as low intervention. This means some studies are early tests of safety and dose, while others compare procedures in larger groups of patients.
  • What kinds of results are measured? Common results include how well surgeons can identify lymph nodes, bile ducts, tumor margins, or parathyroid glands. Other studies measure surgical time, complications, fluorescence visibility, and whether the technique helps avoid problems such as leakage or low calcium.
  • Are these studies only about cancer? No. Many trials are in cancer surgery, but some study gallbladder disease, thyroid surgery, acute cholecystitis, hysterectomy, lipedema, and uveitis. The goal is usually to see whether imaging with Indocyanine Green improves diagnosis or surgery.

Sperimentazioni cliniche in corso su Indocyanine Green

  • Studio sulla dose ottimale di verde di indocianina nella colecistectomia laparoscopica per pazienti con colelitiasi sintomatica

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Spagna

  • Studio sulla tecnica del linfonodo sentinella con pertecnetato di sodio, albumina umana e verde di indocianina per pazienti con tumore ovarico in stadio precoce

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

  • Studio clinico per valutare l’uso di indocianina verde con vescicole extracellulari per la diagnosi di tumori solidi del sistema digestivo operabili

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Italia

  • Studio sulla biopsia del linfonodo sentinella con verde di indocianina e tecnezio (99mTc) nanocolloide in pazienti con melanoma, tumori orali o carcinoma del pene

    In arruolamento

    1 1 1
    Malattie in studio:
    Farmaci in studio:
    Paesi Bassi

  • Indocyanina verde per valutare la vascolarizzazione durante l’exenterazione pelvica in pazienti con cancro ginecologico ricorrente o persistente

    In arruolamento

    1 1 1
    Farmaci in studio:
    Italia

  • Studio sulla vascolarizzazione della fetta vaginale dopo isterectomia totale laparoscopica con iniezione di indocianina verde per pazienti sottoposti a isterectomia totale

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

  • Studio sull’uso di Indocyanine Green per prevenire perdite anastomotiche nei pazienti con cancro colorettale durante la chirurgia

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

  • Studio sull’uso di indocianina verde in pazienti con colecistite acuta che necessitano di chirurgia urgente

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Spagna

  • Studio sull’uso di Indocyanine Green per migliorare la rilevazione intraoperatoria dei tumori epatici in pazienti sottoposti a chirurgia epatica minimamente invasiva

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Spagna

  • Studio sull’efficacia di adalimumab e mycophenolate mofetil in pazienti con uveite non infettiva dipendente da steroidi

    In arruolamento

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

Glossario

  • Clinical trial: A research study in people that tests a medical approach, procedure, or treatment to see how well it works and how safe it is.
  • Interventional study: A study where researchers assign a treatment or procedure and then observe the results.
  • Phase 1/2: An early stage study. Phase 1 focuses more on safety and dose, while Phase 2 looks more at whether the approach seems to work.
  • Phase 3: A larger study that compares approaches in more patients to confirm benefit and collect more safety information.
  • Phase 4: A study done after a method is already in wider use, often to learn more about how it performs in real practice.
  • Sentinel lymph node: The first lymph node or nodes where cancer cells may spread from a tumor. Finding these nodes helps doctors check whether cancer has spread.
  • Fluorescence imaging: A technique that uses special light to make certain tissues visible during surgery.
  • Near-infrared fluorescence: A type of imaging that uses invisible light to help surgeons see structures inside the body during an operation.
  • Biliary structures: Parts of the bile drainage system, including the ducts that carry bile from the liver and gallbladder.
  • Parathyroid glands: Small glands in the neck that help control calcium levels in the blood.
  • Anastomotic leakage: A leak at the place where two parts of the bowel have been joined during surgery.
  • Negative predictive value: A measure of how well a test or technique correctly shows that a disease or metastasis is not present when the result is negative.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sulluso-di-indocianina-verde-e-soluzione-di-albumina-umana-per-la-biopsia-del-linfonodo-sentinella-in-pazienti-con-melanoma-tumori-orali-o-carcinoma-del-pene/
  2. https://clinicaltrials.gov/study/2025-522535-33-00
  3. https://clinicaltrials.gov/study/2023-508316-27-00
  4. https://clinicaltrials.gov/study/2024-513529-21-00
  5. https://studi-clinici.it/studio/studio-sulla-tecnica-del-linfonodo-sentinella-con-pertecnetato-di-sodio-albumina-umana-e-verde-di-indocianina-per-pazienti-con-tumore-ovarico-in-stadio-precoce/
  6. https://clinicaltrials.gov/study/2023-505112-38-00
  7. https://clinicaltrials.gov/study/2025-521273-14-00
  8. https://clinicaltrials.gov/study/2024-518677-34-00
  9. https://clinicaltrials.gov/study/2023-509130-18-00
  10. https://clinicaltrials.gov/study/2024-511966-36-00
  11. https://clinicaltrials.gov/study/2022-502737-26-00
  12. https://clinicaltrials.gov/study/2023-504024-26-00
  13. https://clinicaltrials.gov/study/2024-511467-28-00
  14. https://studi-clinici.it/studio/studio-sulla-permanenza-dellindocianina-verde-nei-linfonodi-ascellari-in-pazienti-con-carcinoma-mammario-e-linfonodi-metastatici/
  15. https://clinicaltrials.gov/study/2024-516255-41-00
  16. https://clinicaltrials.gov/study/2025-523898-42-00
  17. https://studi-clinici.it/studio/studio-sul-cancro-endometriale-a-rischio-intermedio-e-alto-confronto-tra-politica-del-linfonodo-sentinella-e-protocolli-di-stadiazione-iniziale-con-patent-blue-technetium-99mtc-rheniumsulfide-coll/
  18. https://studi-clinici.it/studio/studio-sulluso-di-indocyanine-green-per-prevenire-perdite-anastomotiche-nei-pazienti-con-cancro-colorettale-durante-la-chirurgia/
  19. https://clinicaltrials.gov/study/2024-518783-13-00
  20. https://clinicaltrials.gov/study/2024-514089-37-00