Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07380867

Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.

Early-stage lesions are difficult to identify intraoperatively during colorectal cancer surgery. Therefore, preoperative lesion marking using a colonoscopic approach is crucial to confirm the location and extent of resection during surgery. Preoperative lesion location can help determine the optimal extent of resection, thereby increasing the accuracy of colorectal surgery. This is particularly true for cases requiring surgery after early-stage colorectal cancer or endoscopic tumor resection. Therefore, preoperative marking with indocyanine green (IDG) allows for laparoscopic identification of the lesion. This is crucial because it allows for precise lesion location, thereby enhancing surgical accuracy and preventing the need for unnecessary additional resections.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endoscopic Tattoo of Suspected Colon Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Indocyanine Green (ICG) Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St.Mary's hospital, the Catholic university of Korea

Seoul, 06591, South Korea

About this study

The recently developed indocyanine green (ICG)-hyaluronic acid mixture (LuminoMark™, Hanlim Pharm Co., Seoul, Republic of Korea) is a surgical marker combining indocyanine green with macroaggregated albumin (MAA). Its non-diffusing properties allow for precise lesion targeting. It addresses unmet needs of existing surgical markers, such as skin pigmentation and surgical site contamination. It effectively adsorbs onto cancerous lesions, enabling precise lesion location. Real-time tracking of the pigment allows for clear identification of the lesion's extent of removal, enhancing convenience and usability during surgery. It has already demonstrated superiority over existing labeling methods in a phase 3 clinical trial for breast lesions, receiving approval from the Ministry of Food and Drug Safety. Clinical trials are underway for various cancer types, including gastric and colon cancer, but it remains an over-approved drug.

Therefore, this study aimed to determine the accuracy of endoscopic labeling using a novel luminomarker for preoperative colon cancer lesion marking.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged 19-80 years
  • Clinical T1-2, N0, without distant metastasis on imaging
  • If surgical treatment is required after ESD (endoscopic mucosal resection)*
  • If endoscopic lesion marking is required as determined by the attending physician

Exclusion criteria

  • Patients diagnosed with distant metastases (M1)
  • Severe hepatic or renal dysfunction (Child-Pugh Class C, eGFR <39 mL/min/1.73 m2)
  • Pregnant or lactating women
  • High risk of intestinal obstruction or perforation
  • Patients deemed inappropriate by the investigator (high-risk patients, such as patients with lung or heart disease, risk factors for bleeding, hepatitis virus infection, or other cancers)
  • Patients with a history of hypersensitivity to the luminomarker drug or its components
  • Patients who have experienced skin hypersensitivity to the dye
  • Patients who do not wish to participate in the study

Treatment and study plan

LuminoMark inj. 0.2mL

Drug
  • Endoscopic tattooing with Luminomark on submucosal layer of bowel
  • Location of injection : total 4 sites
  • Left lateral side of the tumor
  • Right lateral side of the tumor
  • opposite side of the tumor
  • distal side of the tumor
  • Dosage of injection: -at least 0.5cc per a site, total 2ml

Primary outcomes

  1. Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing

    Time frame: Perioperative/Periprocedural

    • Mix 1 vial (2 ml) of Indocyanine Green (ICG) + Hyaluronic Acid Mixture (Luminomarker™) with 1 vial (2 ml) of the attached solvent. Shake gently to dissolve thoroughly.
    • After performing an endoscopy to identify the lesion, attach the syringe to the endoscopic injector and mark at least three locations with at least 0.2 cc each.
    • After general anesthesia, insert a trocar for laparoscopic or robotic surgery and insert the laparoscopic equipment. Use a Laparoscopic near-intrared (NIR) camera to confirm the lesion marking.

    After marking with a surgical hemoclip, take a photograph and mark with a hemoclipping. A tumor is confirmed at the ICG-marked location in the obtained specimen.

Secondary outcomes

  1. post-procedure related complication

    Time frame: through postoperative 4 days

    • Check for fever above 38°C (100°F) and abdominal pain before and after the procedure, and any abnormal findings such as free air on a simple X-ray.
    • Check for allergic reactions to medications.
    • Check for any postoperative complications and postoperative pathology results.

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Hanlim Pharm. Co., Ltd.

Registry information

Official study title

Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery

Acronym: Tattooing

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.