LumiSurg Contrast Agents Database

Updated: 2026-04-24

Scope and notes

• Regulatory fields distinguish FDA approval from centralized EMA authorization. Several legacy dyes are marketed in Europe through national pathways even when no centralized EMA authorization exists.
• Clinical-trial coverage is representative rather than exhaustive and emphasizes trials that are commonly cited in surgical imaging workflows.
• Excitation and emission values are nominal peak wavelengths; practical system performance depends on formulation, dose, solvent, and optical filters.
• Experimental agents may have empty trial arrays when no directly relevant ClinicalTrials.gov interventional record was identified by 2026-04-24.

LumiSurg score rubric

• Clinical utility: 4 points
• Regulatory maturity: 4 points
• NIR-II relevance: 2 points
• Interpretation: Higher is better. Scores favor agents with proven intraoperative usefulness and regulatory maturity, while still awarding additional value to true NIR-II relevance.

Summary table

Agent	Window	Ex/Em (nm)	FDA	EMA	Score
Indocyanine Green	NIR-I	805 / 835	approved	not centrally authorized	9.5
Methylene Blue	NIR-I	665 / 686	approved	not centrally authorized	6.0
IRDye 800CW	NIR-I	774 / 789	investigational	investigational	6.8
ZW800-1	NIR-I	770 / 788	investigational	investigational	7.2
CH1055	NIR-II	808 / 1055	preclinical / not approved	preclinical / not approved	5.6
Fluorescein	visible	494 / 521	approved	not centrally authorized	6.4
5-Aminolevulinic Acid	visible	405 / 635	approved	approved	8.7

Indocyanine Green

• Aliases: ICG, Indocyanine Green for Injection, IC-GREEN, SPY Agent Green
• Chemical class: Tricarbocyanine / heptamethine cyanine dye
• Spectral profile: excitation 805 nm; emission 835 nm; window NIR-I
• Regulatory status: FDA approved (1959); EMA not centrally authorized (n/a). Mature, widely adopted small-molecule fluorophore. On-label U.S. use covers angiography, perfusion, and biliary visualization; many oncologic and reconstructive surgery uses are off-label.
• Pharmacokinetics: Rapid hepatic extraction with biliary excretion; minimal renal clearance; strong plasma-protein binding. Half-life: Approximately 3 to 4 minutes after IV dosing. Route: IV for angiography/perfusion; interstitial or submucosal injection is common for lymphatic mapping.
• LumiSurg score: 9.5 / 10

Clinical applications

• Tissue perfusion and angiography
• Intraoperative cholangiography / bile duct visualization
• Sentinel lymph node mapping
• Lymphatic mapping
• Flap and graft perfusion assessment
• Vascular and cerebrovascular fluorescence imaging

Compatible imaging systems

• Stryker SPY-PHI / 1688 AIM family
• Intuitive da Vinci Firefly
• Olympus VISERA ELITE II IR
• Quest Spectrum
• Hamamatsu PDE family

Key clinical trials

• NCT01673022: A Comparison of Sentinel Lymph Node Biopsy to Lymphadenectomy for Endometrial Cancer Staging (FIRES Trial) | N/A | Completed
• NCT01818739: Prospective Clinical Trial of Robotic Sentinel Lymph Node Assessment With Isosulfane Blue and Indocyanine Green in Endometrial Cancer and the Impact of Ultrastaging | N/A | Completed

Manufacturers

• Diagnostic Green
• Akorn
• Multiple generic sterile-injectable manufacturers

Key publications

• 2017: A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial cancer staging (FIRES trial): a multicentre, prospective, cohort study (DOI: 10.1016/S1470-2045(17)30068-2)
• 2023: Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial (DOI: 10.1038/s41467-023-42712-6)

Unmet needs / limitations

• Nonspecific distribution and background signal in inflamed or highly vascular tissue.
• Limited depth penetration and increased attenuation versus true NIR-II imaging.
• Hepatic clearance complicates repeated dosing in severe liver dysfunction.
• Signal depends heavily on timing, concentration, and camera tuning.

Methylene Blue

• Aliases: MB, Methylthioninium chloride, ProvayBlue
• Chemical class: Phenothiazinium / thiazine dye
• Spectral profile: excitation 665 nm; emission 686 nm; window NIR-I
• Regulatory status: FDA approved (2016); EMA not centrally authorized (n/a). Approved therapeutic dye for methemoglobinemia and other legacy indications; intraoperative fluorescence use is mainly off-label and system-dependent.
• Pharmacokinetics: Mixed metabolism and renal excretion; about 40% is excreted unchanged in urine. Half-life: Approximately 24 hours in humans. Route: IV.
• LumiSurg score: 6.0 / 10

Clinical applications

• Parathyroid localization
• Sentinel lymph node mapping
• Ureter visualization
• Biliary anatomy support
• Selected perfusion or leak-assessment workflows with red-edge/NIR systems

Compatible imaging systems

• Quest Spectrum
• Karl Storz IMAGE1 S Rubina
• Fluobeam-class 660 to 700 nm systems
• Custom red-edge fluorescence cameras

Key clinical trials

• NCT02089542: Use of Low-Dose Methylene Blue and Near Infrared Fluorescence in Thyroid and Parathyroid Surgery | Phase 1/Phase 2 | Completed
• NCT01847612: Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Biliary Anatomy During Hepatectomy and Cholecystectomy | N/A | Completed
• NCT00314405: Sentinel Node Identification Using the Fluorescence of Methylene Blue in Breast Cancer | N/A | Completed

Manufacturers

• Provepharm / American Regent
• Multiple generic injectable manufacturers

Key publications

• 2020: Methylene Blue-Current Knowledge, Fluorescent Properties, and Its Future Use (DOI: 10.3390/jcm9113538)
• 2018: Use of methylene blue and near-infrared fluorescence in thyroid and parathyroid surgery (DOI: 10.1007/s00423-017-1641-2)
• 2022: Methylene Blue Near-Infrared Fluorescence Imaging in Breast Cancer Sentinel Node Biopsy (DOI: 10.3390/cancers14071817)

Unmet needs / limitations

• Lower fluorescence efficiency and penetration than 800 nm agents.
• Signal competes with hemoglobin absorption and ambient-light contamination.
• Dose-dependent toxicity and serotonergic/MAOI interaction risk limit liberal use.
• No strong regulatory pathway for image-guided surgical labeling.

IRDye 800CW

• Aliases: IRDye800CW, IRDye 800CW NHS ester, IRDye 800CW carboxylate
• Chemical class: Sulfonated heptamethine cyanine dye
• Spectral profile: excitation 774 nm; emission 789 nm; window NIR-I
• Regulatory status: FDA investigational (n/a); EMA investigational (n/a). Clinical-stage fluorophore platform, most often used as an antibody-, peptide-, or nanobody-conjugated tracer. Not approved as a standalone surgical contrast agent.
• Pharmacokinetics: Conjugate-dependent. Antibody conjugates typically clear through hepatic and reticuloendothelial pathways rather than behaving like a free renal-clearable dye. Half-life: Standalone human half-life is not established for surgical use; conjugates are commonly measured in hours to days. Route: IV as part of a targeted conjugate.
• LumiSurg score: 6.8 / 10

Clinical applications

• Targeted tumor margin delineation
• Head and neck cancer fluorescence-guided surgery
• Colorectal lesion localization when conjugated to anti-EGFR agents
• Fluorescence endoscopy / endonasal applications via bevacizumab or panitumumab conjugates

Compatible imaging systems

• Quest Spectrum
• SurgVision Explorer Air
• PerkinElmer Solaris
• Open-field 800 nm fluorescence cameras used in targeted-tracer trials

Key clinical trials

• NCT01987375: Cetuximab-IRDye800 for Surgical Navigation in Head and Neck Cancer | Phase 1 | Completed
• NCT02415881: Panitumumab-IRDye800CW for Fluorescence Guided Surgical Resection of Colorectal Cancer | Phase 1 | Completed

Manufacturers

• LI-COR Biosciences
• Academic GMP conjugation programs

Key publications

• 2015: Safety and Tumor Specificity of Cetuximab-IRDye800 for Surgical Navigation in Head and Neck Cancer (DOI: 10.1158/1078-0432.CCR-14-3284)
• 2019: Panitumumab-IRDye800CW for Fluorescence-Guided Surgical Resection of Colorectal Cancer (DOI: 10.1016/j.jss.2019.01.065)
• 2018: Safety of panitumumab-IRDye800CW and cetuximab-IRDye800CW for fluorescence-guided surgical navigation in head and neck cancers (DOI: 10.7150/thno.24487)

Unmet needs / limitations

• CMC, toxicology, and regulatory burden must be repeated per conjugated targeting agent.
• Pharmacokinetics vary widely by antibody, peptide, and target density.
• Standalone dye is not a marketed drug-device solution.
• Remains in the NIR-I window, so it does not capture the deeper-tissue advantages promised by NIR-II.

ZW800-1

• Aliases: ZW800-1, ZW800, Nizaracianine triflutate
• Chemical class: Zwitterionic heptamethine cyanine dye
• Spectral profile: excitation 770 nm; emission 788 nm; window NIR-I
• Regulatory status: FDA investigational (n/a); EMA investigational (n/a). Renal-clearable investigational fluorophore with low nonspecific binding. Most advanced programs focus on ureter identification and targeted cRGD conjugates.
• Pharmacokinetics: Predominantly renal clearance with low plasma-protein binding and intentionally low nonspecific tissue uptake. Half-life: Rapid blood clearance; human studies describe useful imaging within minutes and PK on the order of tens of minutes to a few hours depending on formulation and dose schedule. Route: IV.
• LumiSurg score: 7.2 / 10

Clinical applications

• Ureter identification during laparoscopic and robotic surgery
• Low-background anatomic imaging in abdominopelvic procedures
• Tumor targeting as cRGD-ZW800-1 and related conjugates
• Renally cleared contrast where low liver background is important

Compatible imaging systems

• Quest Spectrum
• Karl Storz IMAGE1 S Rubina
• Olympus VISERA ELITE II IR
• Stryker 1688 / SPY-class 800 nm systems

Key clinical trials

• NCT06101745: TRIPHASE Study: A Study of Nizaracianine Triflutate for Ureter Identification During Laparoscopic Surgery | Phase 2/Phase 3 | Recruiting
• NCT04191460: Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer | Phase 2 | Recruiting
• NCT05518071: Fluorescence-guided Surgery Using cRGD-ZW800-1 in Colon Cancer | Phase 2 | Completed

Manufacturers

• Curadel Surgical Innovations
• Academic translational programs developing cRGD-ZW800-1

Key publications

• 2019: A zwitterionic near-infrared fluorophore for real-time ureter identification during laparoscopic abdominopelvic surgery (DOI: 10.1038/s41467-019-11014-1)
• 2024: Double-blind, placebo-controlled phase 1 trial of nizaracianine administered in three divided doses to healthy volunteers (DOI: 10.1016/j.ejso.2024.109155)
• 2026: Pharmacokinetics, safety, tolerability and fluorescence imaging of nizaracianine triflutate administered in three divided doses to healthy volunteers (DOI: 10.1002/bcp.70459)

Unmet needs / limitations

• Still an 800 nm fluorophore rather than a true NIR-II agent.
• Commercial OR integration is earlier-stage than ICG and depends on gaining drug-device workflow approval.
• Most human evidence is focused on ureters and targeted derivatives rather than broad surgical utility.
• Limited large-scale post-dose safety and effectiveness datasets compared with approved dyes.

CH1055

• Aliases: CH1055, Small-molecule NIR-II dye, Representative next-generation NIR-II fluorophore
• Chemical class: Donor-acceptor-donor benzobisthiadiazole small molecule
• Spectral profile: excitation 808 nm; emission 1055 nm; window NIR-II
• Regulatory status: FDA preclinical / not approved (n/a); EMA preclinical / not approved (n/a). Representative next-generation NIR-II small molecule selected because the requested BTC-15 designation could not be corroborated cleanly in current primary literature. CH1055 has strong preclinical relevance but no human approval pathway yet.
• Pharmacokinetics: Predominantly renal in reported small-animal studies, with lower reticuloendothelial background than many nanoparticle SWIR probes. Half-life: No established human half-life; translation remains preclinical. Route: IV in preclinical studies.
• LumiSurg score: 5.6 / 10

Clinical applications

• Preclinical deep-tissue vascular imaging
• Tumor margin imaging in small-animal models
• Lymphatic and ureter imaging research
• Platform development for SWIR surgical systems

Compatible imaging systems

• InGaAs SWIR cameras
• Prototype NIR-II open-field imagers with 808 nm excitation
• Research SWIR laparoscopes and endoscopes

Key clinical trials

• No directly relevant ClinicalTrials.gov interventional study was identified for this standalone agent as of 2026-04-24.

Manufacturers

• Academic research-use synthesis only; no marketed GMP surgical product identified

Key publications

• 2016: A small-molecule dye for NIR-II imaging (DOI: 10.1038/nmat4476)
• 2022: Recent advances in small molecule dye-based nanotheranostics for NIR-II photoacoustic imaging-guided cancer therapy (DOI: 10.3389/fbioe.2022.1002006)

Unmet needs / limitations

• No human surgical data or regulatory filings identified.
• Requires InGaAs/SWIR hardware that is not yet standard in operating rooms.
• Manufacturing, toxicology, and dose-finding pathways remain undeveloped compared with ICG-class dyes.
• Clinical differentiation must be proven against mature 800 nm workflows.

Fluorescein

• Aliases: Fluorescein sodium, AK-FLUOR, Resorcinolphthalein dye
• Chemical class: Xanthene dye
• Spectral profile: excitation 494 nm; emission 521 nm; window visible
• Regulatory status: FDA approved (1976); EMA not centrally authorized (n/a). Approved mainly for ophthalmic angiography; most open surgical and neurosurgical fluorescence use is off-label.
• Pharmacokinetics: Mainly renal excretion, with additional hepatic conjugation. Half-life: Approximately 23 minutes plasma half-life; systemic clearance is largely complete within 48 to 72 hours. Route: IV.
• LumiSurg score: 6.4 / 10

Clinical applications

• High-grade glioma resection support
• Tumors that disrupt the blood-brain barrier
• Ophthalmic angiography
• Selected vascular patency or leak-visualization workflows with visible-light filters

Compatible imaging systems

• Carl Zeiss YELLOW 560
• Leica FL560
• Visible-light microscopes and endoscopes with 520 to 560 nm emission filters

Key clinical trials

• NCT04351373: Fluorescein Sodium in Newly Diagnosed High Grade Glioma Surgery | Phase 3 | Completed
• NCT03291977: Fluorescein Guided Surgery in Cerebral Metastases | Phase 3 | Completed
• NCT02691923: Fluorescein-guided Resection of Malignant Gliomas | Phase 2 | Recruiting

Manufacturers

• Akorn / Long Grove Pharmaceuticals
• Multiple generic injectable manufacturers

Key publications

• 2017: Fluorescein-Guided Surgery for High-Grade Glioma Resection: An Intraoperative “Contrast-Enhancer” (DOI: 10.1016/j.wneu.2017.05.022)
• 2018: Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO) (DOI: 10.1158/1078-0432.CCR-17-1184)
• 2019: Fluorescein Application in Cranial and Spinal Tumors Enhancing at Preoperative MRI and Operated With a Dedicated Filter on the Surgical Microscope: Preliminary Results in 279 Patients Enrolled in the FLUOCERTUM Prospective Study (DOI: 10.3389/fsurg.2019.00049)

Unmet needs / limitations

• Visible emission means higher tissue scattering and lower penetration than NIR dyes.
• Signal depends on blood-brain barrier disruption rather than molecular specificity.
• Ambient-light contamination is harder to control than with NIR systems.
• Regulatory labeling is not built around modern surgical fluorescence guidance.

5-Aminolevulinic Acid

• Aliases: 5-ALA, Aminolevulinic acid hydrochloride, Gleolan, Gliolan
• Chemical class: Heme biosynthesis precursor; prodrug converted intracellularly to fluorescent protoporphyrin IX
• Spectral profile: excitation 405 nm; emission 635 nm; window visible
• Regulatory status: FDA approved (2017); EMA approved (2007). Approved optical imaging agent for fluorescence-guided resection of suspected high-grade glioma. Expansion work in meningioma and device-assisted workflows is ongoing.
• Pharmacokinetics: Rapid systemic elimination of 5-ALA with intracellular conversion to PpIX; metabolites are cleared mainly in urine. Half-life: 5-ALA plasma half-life is about 0.9 hours; fluorescent PpIX half-life is about 3.6 hours. Route: Oral.
• LumiSurg score: 8.7 / 10

Clinical applications

• High-grade glioma resection
• Malignant glioma visualization
• Meningioma development programs
• Adjunctive fluorescence-guided neurosurgery using blue-light microscopes

Compatible imaging systems

• Carl Zeiss BLUE 400
• Leica FL400
• Blue-light neurosurgical microscope platforms tuned for PpIX fluorescence

Key clinical trials

• NCT04305470: Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301) | Phase 3 | Completed
• NCT07111182: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery (ATM5-ALA) | N/A | Recruiting

Manufacturers

• NX Development Corp.
• Photonamic GmbH
• medac GmbH

Key publications

• 2006: Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial (DOI: 10.1016/S1470-2045(06)70665-9)
• 2023: Technical Pearls to Effectively Use 5-ALA in Fluorescence-Guided Tumor Resection—5 Lessons from the Operating Room (DOI: 10.3390/brainsci13030411)
• 2024: Beyond fluorescence-guided resection: 5-ALA-based glioblastoma therapies (DOI: 10.1007/s00701-024-06049-3)

Unmet needs / limitations

• Visible-light workflow requires dedicated blue-light optics and darkened-field interpretation.
• Photosensitivity precautions and oral pre-dose timing complicate perioperative logistics.
• Fluorescence is strongest in high-grade disease and less reliable in infiltrative margins or lower-grade tumors.
• Not a NIR or NIR-II agent, limiting compatibility with many general-purpose fluorescence platforms.