for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around
Principal Investigator
by Sonia L Ramamoorthy, MD
Headshot of Sonia L Ramamoorthy
Sonia L Ramamoorthy



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


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.


Colorectal Neoplasms, Fluorescence, Cancer, SGM-101, Surgery, Colorectal, Recurrence


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:
    • 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.


  • Moores Cancer Center - UCSD Health accepting new patients
    La Jolla California 92093 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCSD

  • Sonia L Ramamoorthy, MD
    Dr. Sonia Ramamoorthy is a surgeon who specializes in surgery of the colon and rectum. She cares for patients who have cancer of the colon, rectum, and anus, as well as benign conditions such as diverticulitis and inflammatory bowel disease. She also specializes in treating pelvic floor disorders and fecal incontinence.


accepting new patients
Start Date
Completion Date
Phase 3 research study
Study Type
Expecting 300 study participants
Last Updated