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

Recruiting now · Phase 3

Conditions studied: Colorectal Neoplasms

In brief

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.

Key facts

Study ID: NCT03659448
Run by: Surgimab
People needed: 300
Starts: 2019-06-17
Expected to finish: 2024-12-01
Last updated by the study team: 2024-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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;
Primary appendiceal cancer;
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);
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;
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Where it is running

Erasmus MC — Rotterdam, Netherlands (enrolling)
Moores Cancer Center - UCSD Health — La Jolla, California, United States (enrolling)
Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
City of Hope National Medical Center — Duarte, California, United States (enrolling)
University of Massachusetts — Worcester, Massachusetts, United States (enrolling)
Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie — Göttingen, Germany (enrolling)
Fondazione IRCCS Policlinico San Matteo — Pavia, Lombardy, Italy (enrolling)
Catharina Ziekenhuis Eindhoven — Eindhoven, Netherlands (enrolling)
Leiden University Medical Center — Leiden, Netherlands (enrolling)
Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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