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NCT07380867Enrolling by invitation

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

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

Source: ClinicalTrials.gov · Last updated 2 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
30 (estimated)
First submitted
21 Dec 2025
Start date
22 Dec 2025
Primary completion date
31 Dec 2026
Lead sponsor
Seoul St. Mary's Hospital
NCT number
NCT07380867

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 22 Dec 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

  • Severe hepatic or renal dysfunction (Child-Pugh Class C, eGFR \<39 mL/min/1.73 m2)

Other

  • Patients diagnosed with distant metastases (M1)
  • Pregnant or lactating women
  • Patients who do not wish to participate in the study

Who the study is looking for

  • 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

Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Seoul St. Mary's Hospital, The Catholic University of Korea
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.