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Clinical Trials in the Netherlands / NCT03659448
Recruiting Phase 3

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

NCT03659448 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Surgimab
Phase
Phase 3
Started
2019-06-17
Last updated
2024-04-24

Condition(s) studied

Colorectal Neoplasms

Investigational drug(s) / intervention(s)

SGM-101

SGM-101: A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Study summary

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer. * Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection. Exclusion Criteria: 1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma; 2. Primary appendiceal cancer; 3. Laboratory abnormalities defined as: * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or; * Total bilirubin above 2 times the ULN or; * Serum creatinine above 1.5 times the ULN or; * Absolute neutrophils counts below 1.5 x 109/L or; * Platelet count below 100 x 109/L or; * Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); 4. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections; 5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
Moores Cancer Center - UCSD Health La Jolla California Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Not Yet Recruiting
University of Massachusetts Worcester Massachusetts Recruiting
Perelman Center for Advanced Medicine Philadelphia Pennsylvania Recruiting
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie Göttingen Germany Recruiting
Fondazione IRCCS Policlinico San Matteo Pavia Lombardy Recruiting
Catharina Ziekenhuis Eindhoven Eindhoven Netherlands Recruiting
Leiden University Medical Center Leiden Netherlands Recruiting
Erasmus MC Rotterdam Netherlands Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03659448 on ClinicalTrials.gov ↗ ← All trials in the Netherlands