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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2023
  • participants needed
    300
  • sponsor
    Surgimab
Updated on 11 May 2022
cancer surgery
metastasis
rectal carcinoma

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.

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.

Details
Condition Colorectal Neoplasms
Treatment SGM-101
Clinical Study IdentifierNCT03659448
SponsorSurgimab
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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

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
Primary appendiceal cancer
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)
Known positive test for human immunodeficiency virus (HIV), hepatitis B surface
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives
antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated
serious infections
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