An interventional study of LuminoMark inj. 0.2mL in Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer and Indocyanine Green (ICG), sponsored by Seoul St. Mary's Hospital. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Diagnostic
Among 282 studies in Colorectal Neoplasms with a site in Korea, Republic of — 60 open to participants now, 96 under way, 12 of them phase 3. Colorectal Neoplasms · Korea, Republic of.
Among the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, this one is the 217th largest by planned enrollment of the 250 interventional ones that give a count, is one of 21 that started in 2025, is one of 44 with no phase, reaches primary completion later than 34 of the 95 other live ones, and was the 273rd registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 30 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →60 of the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of are open now.
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 19 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →282 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 95 · Phase 2 102 · Phase 3 49 · Phase 4 4
First in 1991; this study’s year is marked. 21 started in 2025.
Median enrollment 145 across the 250 interventional studies, 682 across the 32 observational. Of the 152 that completed or were terminated, 56 (37%) have results posted.
170 of 282 have an industry lead sponsor. The 10 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 2 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
27 of the studies in Colorectal Neoplasms with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05093907BeyondBio Inc.A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Capecitabine in Patients with Metastatic Colorectal Cancer | 2026-11-30 |
| NCT05784688TiumBio Co., Ltd.Study of TU2218 in Combination With KEYTRUDA®(Pembrolizumab) in Patients With Advanced Solid Tumors | 2026-12 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
| NCT06769087Seoul St. Mary's HospitalComparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery | 2026-12-31 |
| NCT07380867Seoul St. Mary's HospitalConfirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery. | 2026-12-31 |
Among the 282 studies in Colorectal Neoplasms with a site in Korea, Republic of, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
* 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
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.
Time frame: Perioperative/Periprocedural
post-procedure related complication
* 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.
Time frame: through postoperative 4 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 12 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Seoul St. Mary's Hospital