Actively Recruiting
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Led by Surgimab · Updated on 2024-04-24
300
Participants Needed
11
Research Sites
284 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for curative colorectal cancer surgery for primary cT4 colon cancer, primary cT3/4 rectal cancer, recurrent colorectal cancer, or peritoneal metastasized colorectal cancer
- Female patients must be of non-child-bearing potential or women of child-bearing potential must have a negative urine pregnancy test on the day of injection
- Women of child-bearing potential must agree to use adequate contraception for 30 days before and 30 days after administration of the investigational product
- Participants must be 18 years of age or older
You will not qualify if you...
- Patients with other active malignancies or malignancies diagnosed within the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma
- Patients with primary appendiceal cancer
- Laboratory abnormalities including liver enzymes above 5 times the upper limit of normal (ULN), total bilirubin above 2 times ULN, serum creatinine above 1.5 times ULN, absolute neutrophil counts below 1.5 x 10^9/L, platelet count below 100 x 10^9/L, or hemoglobin below 4 mmol/L (females) or 5 mmol/L (males)
- Known positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody, or patients with untreated serious infections
- Any condition that the investigator considers potentially jeopardizing the patient's well-being or study objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Moores Cancer Center - UCSD Health
La Jolla, California, United States, 92093
Actively Recruiting
3
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
5
University of Massachusetts
Worcester, Massachusetts, United States, 01655
Actively Recruiting
6
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Göttingen, Germany, 37075
Actively Recruiting
8
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, Italy, 27100
Actively Recruiting
9
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Actively Recruiting
10
Leiden University Medical Center
Leiden, Netherlands, 2333 CL
Actively Recruiting
11
Erasmus MC
Rotterdam, Netherlands, 3015
Actively Recruiting
Research Team
J
John Warner, JD, MPA
CONTACT
F
Françoise Cailler, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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