Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
NCT ID: NCT03659448
Last Updated: 2024-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2019-06-17
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Treatment
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.
SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
No Treatment
Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.
No interventions assigned to this group
Interventions
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SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Surgimab
INDUSTRY
Responsible Party
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Principal Investigators
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Alex L. Vahrmeijer,, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center, Leiden, The Netherlands
Locations
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City of Hope National Medical Center
Duarte, California, United States
Moores Cancer Center - UCSD Health
La Jolla, California, United States
Cleveland Clinic Florida
Weston, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Göttingen, , Germany
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy
Catharina Ziekenhuis Eindhoven
Eindhoven, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SGM-CLIN03
Identifier Type: -
Identifier Source: org_study_id
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