Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion
Sonia L Ramamoorthy

Description

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.

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

Details

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.

Keywords

Colorectal Neoplasms Fluorescence Cancer SGM-101 Surgery Colorectal Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  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:
  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. 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. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.

Locations

  • Moores Cancer Center - UCSD Health accepting new patients
    La Jolla California 92093 United States
  • Cleveland Clinic Florida accepting new patients
    Weston Florida 33331 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Surgimab
ID
NCT03659448
Phase
Phase 3
Study Type
Interventional
Last Updated