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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03659448
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : May 5, 2022
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: SGM-101 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two parallel arms consisting of a treatment arm of patients who will receive the study drug and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR, and a no treatment arm to whom the study drug will not be administered and who will undergo surgical resections under standard "white light" conditions only.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Active Comparator: 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.
Drug: SGM-101
A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

No Intervention: No Treatment
Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.

Primary Outcome Measures :
  1. Surgical resection histopathology. [ Time Frame: Through completion of surgery, up to 9 weeks. ]
    Comparison of surgical resections using histopathology as standard of truth..

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03659448

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Contact: John Warner, JD, MPA 8123257657
Contact: Françoise Cailler, PhD +33 467 798 381

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United States, California
Moores Cancer Center - UCSD Health Recruiting
La Jolla, California, United States, 92093
Contact: Sonia L Ramamoorthy, MD    858-657-6100   
Contact: Dad Shakeela, Ph.D.    (858) 822-5376   
Principal Investigator: Sonia L Ramamoorthy, MD         
Sub-Investigator: Andrew Lowy, MD         
Sub-Investigator: Joel Baumgartner, MD         
Sub-Investigator: Rebekah White, MD         
Sub-Investigator: Kaitlyn Kelly, MD         
Sub-Investigator: Jason Sicklick, MD         
Sub-Investigator: Nicole Lopez, MD         
Sub-Investigator: Jula Veerapong, MD         
Sub-Investigator: Samuel Eisenstein, MD         
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: David J MARON, MD    954-659-5278   
Contact: Maria MEJIA, BS, CCRP    (954) 659-5888   
Principal Investigator: David J Maron, MD         
Sub-Investigator: Steven Wexner, MD         
Sub-Investigator: Eric Weiss, MD         
Sub-Investigator: Giovanna DaSilva, MD         
Sub-Investigator: Dana Sands, MD         
Sub-Investigator: Conrad Simpfendorfer, MD         
Sub-Investigator: Mayank Roy, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Rocco Ricciardi, MD   
Contact: Caitlin Stafford    617-643-7869   
Principal Investigator: Rocco Ricciardi, MD         
Sub-Investigator: Horoko Kunitake, MD         
Sub-Investigator: Richard Hodin, MD         
Sub-Investigator: Liliana Bordeianou, MD         
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Sharon Balcom, RN    508-334-4918   
Principal Investigator: Karim Alavi, MD         
United States, Pennsylvania
Perelman Center for Advanced Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal, MD   
Sub-Investigator: Najjia Mahmoud, MD         
Principal Investigator: Sunil Singhal, MD         
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie Recruiting
Göttingen, Germany, 37075
Contact: Jens Sperling, MD    +49 551 39 7989   
Contact: Johanna Kreutzer, Ph.D.   
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Lombardia, Italy, 27100
Contact: Luigi Pugliese, MD   
Principal Investigator: Andrea Pietrabissa, MD         
Catharina Ziekenhuis Eindhoven Recruiting
Eindhoven, Netherlands
Contact: H J Rutten, MD, PhD    +31 40 2397150   
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 CL
Contact: Alexander L Vahrmeijer, MD, Ph.D.    +31 71 5262309   
Contact: Ruben P Meijer, MD    ‭+31 71 7517143   
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015
Contact: Cornelis Verhoef, MD   
Contact: Job Kooten, MD   
Principal Investigator: Cornelis Verhoef, MD         
Sponsors and Collaborators
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Principal Investigator: Alex L. Vahrmeijer,, MD, PhD Leiden University Medical Center, Leiden, The Netherlands
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Responsible Party: Surgimab Identifier: NCT03659448    
Other Study ID Numbers: SGM-CLIN03
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Surgimab:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathologic Processes
Disease Attributes