Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
- Registration Number
- NCT03659448
- Lead Sponsor
- Surgimab
- Brief 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.
- Detailed Description
The performance of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer will be compared to that of standard "white light" visualization in a multicenter, open-label, randomized, controlled, parallel arms clinical study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
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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;
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Primary appendiceal cancer;
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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);
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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;
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Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment SGM-101 Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.
- Primary Outcome Measures
Name Time Method Surgical resection histopathology. Through completion of surgery, up to 9 weeks. Comparison of surgical resections using histopathology as standard of truth..
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Erasmus MC
🇳🇱Rotterdam, Netherlands
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
🇩🇪Göttingen, Germany
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Lombardia, Italy
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Catharina Ziekenhuis Eindhoven
🇳🇱Eindhoven, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Moores Cancer Center - UCSD Health
🇺🇸La Jolla, California, United States
Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States