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

NCT07380867 | Enrolling By Invitation

• 1 other identifier: KC25MASI0456
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Indocyanine Green (ICG); Endoscopic Tattoo of Suspected Colon Cancer

Keywords

endoscopic tattooing; colorectal cancer; indocyanine green; LuminoMark

Outcome Measures

Primary Outcomes (1)

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

  * 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.

  Perioperative/Periprocedural

Secondary Outcomes (1)

• post-procedure related complication

  through postoperative 4 days

Study Arms (1)

Luminomarker injection

EXPERIMENTAL

Through endoscopy, Luminomarker injection on submucosal layer. Location of injection : total 4 sites around tumor 1. Left lateral side of tumor 2. Right lateral side of tumor 3. opposite of tumor (180 degree) 4. distal part of 2cm from the tumor dosage of injection : at least 0.5cc per a site , total 2cc

Drug: LuminoMark inj. 0.2mL

Interventions

LuminoMark inj. 0.2mL DRUG

* Endoscopic tattooing with Luminomark on submucosal layer of bowel * Location of injection : total 4 sites 1. Left lateral side of the tumor 2. Right lateral side of the tumor 3. opposite side of the tumor 4. distal side of the tumor * Dosage of injection: -at least 0.5cc per a site, total 2ml

Luminomarker injection

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Hanlim Pharm. Co., Ltd.: collaborator

Study Sites (1)

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

Seoul, Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: * 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

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 2, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-12

Locations

KR (1)