RECRUITING

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

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Conditions

Colorectal NeoplasmsFluorescenceCancerSGM-101SurgeryColorectal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-06-17
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03659448

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  1. 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. 2. Primary appendiceal cancer;
  3. 3. Laboratory abnormalities defined as:
  4. * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or;
  5. * Total bilirubin above 2 times the ULN or;
  6. * Serum creatinine above 1.5 times the ULN or;
  7. * Absolute neutrophils counts below 1.5 x 109/L or;
  8. * Platelet count below 100 x 109/L or;
  9. * Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);
  10. 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;
  11. 5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Contacts and Locations

Study Contact

John Warner, JD, MPA
CONTACT
8123257657
johna.warner@outlook.com
Françoise Cailler, PhD
CONTACT
+33 467 798 381
fcailler@surgimab.com

Principal Investigator

Alex L. Vahrmeijer,, MD, PhD
PRINCIPAL_INVESTIGATOR
Leiden University Medical Center, Leiden, The Netherlands

Study Locations (Sites)

City of Hope National Medical Center
Duarte, California, 91010
United States
Moores Cancer Center - UCSD Health
La Jolla, California, 92093
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Massachusetts
Worcester, Massachusetts, 01655
United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Surgimab

  • Alex L. Vahrmeijer,, MD, PhD, PRINCIPAL_INVESTIGATOR, Leiden University Medical Center, Leiden, The Netherlands

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-17
Study Completion Date2024-12

Study Record Updates

Study Start Date2019-06-17
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Fluorescence
  • Cancer
  • SGM-101
  • Surgery
  • Colorectal

Additional Relevant MeSH Terms

  • Colorectal Neoplasms