Using SGM-101 to improve tumor visualization during colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of SGM-101, a specialized imaging agent, in enhancing the visualization of primary and recurrent tumors as well as metastases during surgical procedures for colorectal cancer. The study compares the performance of SGM-101 against standard white light visualization in a multicenter, open-label, randomized, controlled format. Patients undergoing curative surgery for colorectal cancer will be enrolled to assess whether SGM-101 can provide better delineation of cancerous tissues, potentially leading to improved surgical outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope National Medical Center
  Duarte, California, United States Recruiting
• Moores Cancer Center - UCSD Health
  La Jolla, California, United States Recruiting
• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting
• University of Massachusetts
  Worcester, Massachusetts, United States Recruiting
• Perelman Center for Advanced Medicine
  Philadelphia, Pennsylvania, United States Recruiting
• Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
  Göttingen, Germany Recruiting

Study contacts

• Principal investigator: Alex L. Vahrmeijer,, MD, PhD — Leiden University Medical Center, Leiden, The Netherlands
• Study coordinator: John Warner, JD, MPA
• Email: johna.warner@outlook.com
• Phone: 8123257657

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biomarkers in Colorectal Cancer: A Longitudinal Study Using Biobanks and Blood Samples

  This study tests whether clinical and molecular biomarkers from tumor tissue and blood can predict treatment response, recurrence, and survival in adults with colorectal cancer undergoing surgery.

  Recruiting at 2 sites Vorarlberg Institute for Vascular Investigation and Treatment · Bregenz, Vorarlberg and 3 other locations · NCT07913802

• Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery

  Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.

  Recruiting Semmelweis University · Budapest · NCT07896174

• ctDNA blood test to spot buried cancer after surgery or treatment in colorectal cancer

  A blood test that looks for specific KRAS mutations in circulating tumor DNA to see if colorectal cancer has left residual disease or is likely to relapse.

  Recruiting Masaryk Memorial Cancer Institute · Brno, Czech Republic · NCT07895459

• Multimodal Survival Predictor for Colorectal Liver Metastases After Surgery

  Researchers are testing a tool that combines MRI-derived tumor features with clinical data to predict survival after surgery for colorectal liver metastases.

  Recruiting Anhui Provincial Hospital · Hefei, Anhui · NCT07830576

• Methylscape test in body fluids for multi-cancer detection in Colombia

  A simple blood, urine, or saliva test called Methylscape is being tested to see if it can detect multiple cancers and identify where the signal is coming from, using people with cancer and healthy volunteers in Colombia.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07741435

• AI-powered stool image analysis to see if it matches FIT results in colorectal cancer screening

  We’re testing whether AI-derived features from stool images can align with FIT results in adults being screened or evaluated for colorectal neoplasia.

  Recruiting Servicio de Salud Metropolitano Sur Oriente · Santiago, Santiago Metropolitan · NCT07740122

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.