Indocyanine Green
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | IC-GREEN | — | 2024-12-05 | fda.gov ↗ |
| Label expansion | US (FDA) | SPY AGENT GREEN KIT | — | 2023-06-05 | fda.gov ↗ |
| Approved | US (FDA) | IC-GREEN | — | 1959-02-09 | fda.gov ↗ |
Trials 181 · started per year
Also used as a comparator or background therapy in 24 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07613931 Background | Jul → Sep 2026 expected | lymphedema | Tactile Medical | Recruiting | No outcome recorded |
| Phase 0 | NCT02851368 Background | Nov 2016 → Nov 2017 | pulmonary coin lesion | University of Pittsburgh | Completed | No outcome recorded |
| Phase 0 | NCT02359578 Background | Aug → Nov 2014 | — | Centre Hospitalier Universitaire Saint Pierre | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT05937269 Background | Oct 2023 → Feb 2026 overdue | head and neck cancer, lymphedema | The University of Texas Health Science Center, Houston | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT06939946 Background | Sep 2023 → Aug 2025 | parathyroid gland disorder, thyroid gland disorder | OPTOSURGICAL, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02070627 Background | Jul 2013 → Aug 2014 | acute cholecystitis | Ohio State University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02946021 Background | Oct 2016 → Feb 2018 | head and neck cancer, lymphedema | Tactile Medical | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06327490 Background | Oct 2024 → Jun 2028 expected | breast cancer | University of Florida | Recruiting | No outcome recorded |
| Phase 2 | NCT04987281 Background | Jan 2022 → Dec 2023 | non-small cell lung carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05229874 Comparator | Jan 2022 → Mar 2023 | gastric cancer | Hebei Medical University | Unknown | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04759820 Comparator | Jan 2021 → Jun 2022 | — | LI XIN-XIANG | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT06845306 Comparator | Jun 2025 → Jul 2026 overdue | malignant colon neoplasm | Vadim Kuznetsov | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05646316 Background | Dec 2022 → Oct 2026 expected | uterine cancer | NRG Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT05168839 Background | Sep 2022 → Oct 2025 overdue | colorectal cancer | Centre Hospitalier Universitaire de Besancon | Recruiting | No outcome recorded |
| Phase 3 | NCT03557827 Comparator | Mar 2018 → Dec 2019 | periodontal disorder | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05709548 Comparator | Mar 2023 → Dec 2025 | acute cholecystitis | Corporacion Parc Tauli | Unknown | No outcome recorded |
| Phase 4 | NCT05332405 Background | May 2022 → Oct 2023 | cubital tunnel syndrome | NYU Langone Health | Withdrawn | No outcome recorded |
| Phase 4 | NCT06629415 Comparator | May 2022 → May 2023 | cholecystitis | Theodor Bilharz Research Institute | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT06672224 Background | Aug 2025 → Aug 2026 | breast carcinoma, lymphatic system disorder | City of Hope Medical Center | Withdrawn | No outcome recorded |
| — | NCT03572998 Background | Sep 2018 → Feb 2019 | lymphedema | University of Aarhus | Unknown | No outcome recorded |
| — | NCT04056923 Comparator | Jan → Jun 2018 | lung cancer, pulmonary coin lesion | Wen-zhao ZHONG | Completed | No outcome recorded |
| — | NCT02508298 Comparator | Apr 2014 → Jul 2018 | cirrhosis of liver, portal hypertension | VA Connecticut Healthcare System | Completed | No outcome recorded |
| — | NCT01969448 Background | Mar 2013 → Apr 2016 | ductal breast carcinoma in situ | Washington University School of Medicine | Completed | No outcome recorded |
| — | NCT00137254 Comparator | Dec 2005 → Feb 2007 | — | United States Army Institute of Surgical Research | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 214 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | indocyanine green | “The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying...” NCT04393168 ↗201“The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov...” NCT05859971 ↗ “Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to...” NCT02946021 ↗ “Patients enrolled in the study will undergo peritumoral injection of near-infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the...” NCT03097575 ↗ “Clinical, bacterial, and inflammatory outcomes of indocyanine green-mediated photodynamic therapy for treating periimplantitis among diabetic patients: A randomized controlled...” NCT04833569 ↗ “The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative...” NCT04785443 ↗ “We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage.” PMID 39151436 ↗ Aug 2024 “This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system.” NCT06222645 ↗ “Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma” NCT01834469 ↗ “Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.” NCT06845306 ↗ “they will receive a dermal injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if breast cancer” NCT03294330 ↗ “Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw.” NCT05937269 ↗ “Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.” NCT07658768 ↗ “near-infrared fluorescence cholangiography with indocyanine green (NIRFC-ICG) is one of the latest additions.” PMID 36868593 ↗ Mar 2023 “Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks” NCT06258486 ↗ “Self-assembled nanoprobes of Indocyanine Green (ICG) and Cisplatin mixed with lipiodol” NCT07295262 ↗ “Investigational product: Indocyanine green (ICG), intravenous administration” NCT07195331 ↗ “intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.” NCT02920216 ↗ “an imaging contrast agent called indocyanine green, also known as ICG” NCT01962649 ↗ “NIR-guided sentinel lymph node mapping with indocyanine green (ICG)” NCT01121718 ↗ “The intervention to be administered is the drug indocyanine green.” NCT03097627 ↗ “The intervention to be administered is indocyanine green dye.” NCT00264602 ↗ “indocyanine green (ICG)-loaded polymeric nanoparticles” NCT07316023 ↗ “indocyanine green (ICG) clearance” NCT02516319 ↗ “ICG (Indocyanine Green)” NCT06647901 ↗ “indocyanine green (ICG)” NCT06994949 ↗ “Drug: Indocyanine Green” NCT03579979 ↗ “Indocyanine Green” NCT06446648 ↗ |
| Known as | IC-Green | “Indocyanine Green (IC-Green)” NCT07613931 ↗ |
| Known as | ICG | “Several cohort studies have shown that indocyanine green (ICG) combined with fluorescent near-infrared imaging is a feasible and reproducible technique for real-time...” PMID 35365509 ↗ Apr 202278“Dosage Form: Intravenous injection Dosage: 0.1 - 0.5 mg/kg of Indocyanine Green (ICG) Frequency: Single administration during surgery Duration: Real-time imaging performed...” NCT07254845 ↗ “Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with...” NCT03850158 ↗ “PURPOSE: To carry out a prospective investigation of the functional and morphological outcome of idiopathic epiretinal membrane (IEM) surgery with or without the assistance of...” PMID 17186261 ↗ Dec 2006 “This study aims to look at babies having a primary or delayed primary oesophageal repair for OA with dTOF to evaluate if using Indocyanine green (ICG) and near infrared...” NCT05735964 ↗ “The purpose of this research study is to assess the feasibility of using a different dye and imaging device, indocyanine green (ICG)-fluorescent imaging through the Asimov...” NCT05859971 ↗ “Indocyanine Green (ICG) is a non-radioactive, fluorescent compound with several clinical applications including angiography for ophthalmologic testing, visualization during...” NCT07513038 ↗ “a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in...” NCT05092750 ↗ “Indocyanine green (ICG), administered intravenously at a dose of 2.5 mg/ml, will be used during surgery to evaluate bowel anastomosis perfusion through near-infrared...” NCT06871787 ↗ “This intervention involves the intravenous injection of the fluorescent contrast agent Indocyanine Green (ICG), followed by imaging with a near-infrared fluorescence camera system.” NCT06222645 ↗ “Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016.” NCT06579430 ↗ “Injecting indocyanine green (ICG) and using its fluorescent characteristics has the advantage of adding information about the vascular supply of the parathyroid glands.” NCT05117853 ↗ “Feasibility Study of the (Intravenously Injected) Indocyanine Green (ICG) Imaging of Tumoral Implants in Patients With Peritoneal Carcinomatosis From Ovarian Carcinoma” NCT01834469 ↗ “Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).” NCT02946021 ↗ “The sole medication used in this experiment is the fluorescent contrast agent that has been clinically used for over 40 years - Indocyanine Green (ICG).” NCT06840418 ↗ “To evaluate the feasibility of using indocyanine green (ICG) to estimate the vascularization of the resected zone during a laparoscopic rectal shaving.” PMID 32646588 ↗ Jul 2020 “In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery.” NCT04719156 ↗ “Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively.” NCT06421103 ↗ “Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.” NCT02949726 ↗ “Indocyanine green (ICG) is a well-known diagnostic reagent that is approved for clinical use in the study of liver function and cardiac output.” NCT06755554 ↗ “endoscopic peritumoral submucosal injection of indocyanine green (ICG) for fluorescence detection of SLN using a near-infrared (NIR) camera.” PMID 28919031 ↗ Aug 2017 “Indocyanine green (ICG) is the most commonly used imaging agent for the diagnosis of tumors and metastatic lymph nodes in clinical settings.” PMID 35770339 ↗ Jun 2022 “Near-infrared fluorescence imaging using intravenous indocyanine green (ICG) facilitates intraoperative identification of biliary anatomy.” PMID 36728303 ↗ Jan 2023 “Indocyanine green (ICG) is a medication that binds to blood vessels and can be visualized using special cameras in the operating room.” NCT04904081 ↗ “they will receive a dermal injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if breast cancer” NCT03294330 ↗ “Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-3 hours prior to surgery.” NCT07315841 ↗ “Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw.” NCT05937269 ↗ “Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.” NCT07658768 ↗ “indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies” NCT02117310 ↗ “Participants diagnosed with brain tumors will receive an intravenous injection of Indocyanine Green (ICG) during surgery.” NCT06867978 ↗ “Indocyanine Green (ICG): Indocyanine green is a water-soluble, NIR fluorophore with a molecular weight of 774.9 kDA.” NCT05346380 ↗ “Indocyanine Green (ICG) is used to guide the extent of D3 lymph node dissection during right hemicolectomy.” NCT07060443 ↗ “Indocyanine green (ICG) is administered intravenously 1 hour before emergency laparoscopic cholecystectomy.” NCT07551388 ↗ “Indocyanine green (ICG) has emerged as a promising tool for improving liver tumour detection.” PMID 41991264 ↗ Apr 2026 “indocyanine green (ICG) as an adjunct to nonsurgical treatment of chronic periodontitis” NCT02043340 ↗ “the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery” NCT06845306 ↗ “However, fluorescent developer Indocyanine Green（ICG） still lacks standardization” NCT05926856 ↗ “Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery” NCT01993576 ↗ “Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant” NCT03204201 ↗ “Indocyanine green (ICG) is a type of dye that is used in medical diagnostics.” NCT04752137 ↗ “Investigational product: Indocyanine green (ICG), intravenous administration” NCT07195331 ↗ “Intraoperative fluorescence angiography (IOFA) with indocyanine green (ICG).” NCT05168839 ↗ “25 mg of indocyanine green (ICG), reconstituted in 10 ml of sterile water” NCT06169735 ↗ “Indocyanine green (ICG) injection for intraoperative lymph node imaging” NCT07638956 ↗ “Administration of Indocyanine Green (ICG) and Visualization of Tumor” NCT05746104 ↗ “NIR-guided sentinel lymph node mapping with indocyanine green (ICG)” NCT01121718 ↗ “Drug: Indocyanine Green (ICG)-Assisted Ureteral Identification” NCT07144904 ↗ “Intravenous Injection Injection of Indocyanine Green (ICG)” NCT06629415 ↗ “indocyanine green (ICG)-loaded polymeric nanoparticles” NCT07316023 ↗ “using the Indocyanine green dye (ICG) during surgery.” NCT04591028 ↗ “intravenous administration of indocyanine green (ICG)” NCT03097627 ↗ “perioperative application of Indocyanine green (ICG)” NCT02775838 ↗ “indocyanine green (ICG)-guided near-infrared imaging” NCT07303231 ↗ “Indocyanine Green (ICG) fluorescence imaging” NCT05687617 ↗ “Indocyanine green (ICG) for injection” NCT01873716 ↗ “Indocyanine Green for Injection (ICG)” NCT04173676 ↗ “Injection of indocyanine green (ICG)” NCT02070640 ↗ “indocyanine green (ICG) clearance” NCT02516319 ↗ “Drug: Indocyanine Green (ICG)” NCT02070627 ↗ “Drug: Indocyanine Green (ICG)” NCT04511026 ↗ “Drug: Indocyanine Green (ICG)” NCT02710240 ↗ “Drug: Indocyanine green (ICG)” NCT01410734 ↗ “Drug: indocyanine green (ICG)” NCT02910726 ↗ “Indocyanine Green (ICG)” NCT07108855 ↗ “Indocyanine Green (ICG)” NCT01424215 ↗ “indocyanine green (ICG)” NCT02473159 ↗ “Indocyanine green (ICG)” NCT03969108 ↗ “Indocyanine green (ICG)” NCT02423148 ↗ “Indocyanine green (ICG)” NCT01204554 ↗ “ICG (Indocyanine Green)” NCT07406815 ↗ “indocyanine green (ICG)” NCT02817334 ↗ “Indocyanine Green (ICG)” NCT07149207 ↗ “ICG (Indocyanine Green)” NCT01693484 ↗ “indocyanine green (ICG)” NCT06994949 ↗ “Indocyanine-Green(ICG)” NCT03793322 ↗ “IC-Green (ICG)” NCT03953144 ↗ |
| Known as | ICG Dye | “Drug: ICG Dye” NCT02516319 ↗ |
| Known as | indocyanine green (IC-Green). | “indocyanine green (IC-Green).” NCT02111824 ↗ |
| Known as | Indocyanine green (ICG) | “Indocyanine green (ICG)” NCT05419947 ↗ |
| Known as | Indocyanine Green Dye | “2.0 mg/kg ICG (Indocyanine Green Dye) as per standard protocol” NCT04719156 ↗ |
| Known as | INFRACYANINE | “indocyanine green (INFRACYANINE© 25mg/10mL).” NCT04842162 ↗ |
| Known as | Near Infrared Imaging | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01808417 ↗ |
| Known as | Perio green | “Indocyanine green (Perio green, Elexxion AG, Radolfzell, Germany) prepared and applied according to manufacturer's instructions steps (mixing, application, soaking phase,...” NCT06379438 ↗ |
| Known as | PULSION | “0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously” NCT03332004 ↗1“0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®” NCT03935165 ↗ |
| Known as | SWIG | “More recently, we described Second Window Indocyanine Green (SWIG) which targets neoplastic tissue through enhanced vascular permeability.” PMID 32514886 ↗ Oct 2020 |
| Known as | TumorGlow | “Subjects will undergo infusion of 5 mg/kg indocyanine green, ICG ("TumorGlow") intravenously up to 5-days prior to surgery.” NCT07658768 ↗ |
| Known as | VERDYE Diagnostic Green | “0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®” NCT03935165 ↗ |
| Modality | Diagnostic / imaging agent | “near-infrared-guided detection of tumor-specific sentinel lymph nodes” NCT00264602 ↗ |
| Route | Intravenous | “IV administration of ICG” NCT00137254 ↗ |