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NCT03659448 | RECRUITING | Colorectal Neoplasms

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

Condition or disease

Colorectal Neoplasms

Intervention/treatment

SGM-101

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
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 : 2019-06-17
Estimated Primary Completion Date : 2024-11
Estimated Study Completion Date : 2024-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Location Details

NCT03659448

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope National Medical Center

Duarte, California, United States, 91010

RECRUITING

United States, California

Moores Cancer Center - UCSD Health

THE JOLLA, California, United States, 92093

RECRUITING

United States, Florida

Cleveland Clinic Florida

Weston, Florida, United States, 33331

NOT YET RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

University of Massachusetts

Worcester, Massachusetts, United States, 01655

RECRUITING

United States, Pennsylvania

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

Germany,

University Medicine Göttingen, Clinic for General Visceral and Pediatric Surgery

Göttingen, Germany, 37075

RECRUITING

Italy, Lombardy

IRCCS Policlinico San Matteo Foundation

Pavia, Lombardy, Italy, 27100

RECRUITING

Netherlands,

Catharina Hospital Eindhoven

Eindhoven, Netherlands,

RECRUITING

Netherlands,

Leiden University Medical Center

Leiden, Netherlands, 2333 CL

RECRUITING

Netherlands,

Erasmus MC

Rotterdam, Netherlands, 3015