Clinical Trials in the USA / NCT03659448
Recruiting
Phase 3
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
NCT03659448 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Colorectal Neoplasms
Investigational drug(s) / intervention(s)
SGM-101
SGM-101: A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Surgical resection histopathology. — Through completion of surgery, up to 9 weeks.
Comparison of surgical resections using histopathology as standard of truth..
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | Recruiting |
| Moores Cancer Center - UCSD Health | La Jolla | California | Recruiting |
| Cleveland Clinic Florida | Weston | Florida | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| University of Massachusetts | Worcester | Massachusetts | Recruiting |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | Recruiting |
| Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie | Göttingen | Germany | Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardy | Recruiting |
| Catharina Ziekenhuis Eindhoven | Eindhoven | Netherlands | Recruiting |
| Leiden University Medical Center | Leiden | Netherlands | Recruiting |
| Erasmus MC | Rotterdam | Netherlands | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03659448 on ClinicalTrials.gov ↗ ← All trials in the USA