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Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
NCT03659448 · Surgimab
In plain English
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Official title
Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-06-17
Estimated completion: 2024-12
Last updated: 2024-04-24
Interventions
Drug: SGM-101
Primary outcomes
- • Surgical resection histopathology. (Through completion of surgery, up to 9 weeks.)
Sponsor
Surgimab · industry
Contacts & investigators
ContactJohn Warner, JD, MPA · contact · johna.warner@outlook.com · 8123257657
ContactFrançoise Cailler, PhD · contact · fcailler@surgimab.com · +33 467 798 381
InvestigatorAlex L. Vahrmeijer,, MD, PhD · principal_investigator, Leiden University Medical Center, Leiden, The Netherlands
All locations (11)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
Moores Cancer Center - UCSD HealthRecruiting
La Jolla, California, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
University of MassachusettsRecruiting
Worcester, Massachusetts, United States
Perelman Center for Advanced MedicineRecruiting
Philadelphia, Pennsylvania, United States
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und KinderchirurgieRecruiting
Göttingen, Germany
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Lombardy, Italy
Catharina Ziekenhuis EindhovenRecruiting
Eindhoven, Netherlands
Leiden University Medical CenterRecruiting
Leiden, Netherlands
Erasmus MCRecruiting
Rotterdam, Netherlands