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SGM-101 for Colorectal Cancer Surgery

This study is testing a new imaging agent called SGM-101 during surgery for colorectal cancer. SGM-101 is a special dye (fluorochrome-labeled) that attaches to a protein called CEA (carcinoembryonic antigen) often found on cancer cells. Doctors will use SGM-101 to help see primary tumors, recurrent cancer, and cancer that has spread (metastases) more clearly during surgery, comparing it to standard "white light" vision. You may be able to join if you are scheduled for surgery for certain types of colorectal cancer, including primary colon or rectal cancer, recurrent colorectal cancer, or cancer that has spread to the lining of the abdomen (peritoneal metastasized). The main goal is to see how well SGM-101 helps doctors identify cancer during surgery, which will be checked by looking at the removed tissue under a microscope.

Study design
This is a multicenter, open-label, randomized, controlled study with two groups of participants, aiming to enroll 300 people.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured through the completion of surgery, up to 9 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03659448

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

Recruiting
PHASE3Ages 18+Interventional
Surgimab
~300 participants
Updated 2024-04-24 on ClinicalTrials.gov
What's tested:SGM-101

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical resection histopathology.
Measured over Through completion of surgery, up to 9 weeks.

Conditions

Colorectal Neoplasms

Explore related trials

Colorectal Carcinoma

Where it's being run

11 sites across 7 states
Netherlands3
California2
Massachusetts2
Florida1
Pennsylvania1
Germany1
Lombardy1

Study leadership

  • Alex L. Vahrmeijer,, MD, PhD · PRINCIPAL_INVESTIGATOR · Leiden University Medical Center, Leiden, The Netherlands

Who to contact

John Warner, JD, MPA
[email protected]
8123257657
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Surgical resection histopathology.Through completion of surgery, up to 9 weeks.

    Comparison of surgical resections using histopathology as standard of truth..