Actively Recruiting
SGM-101 in Colorectal Brain Metastases.
Led by Leiden University Medical Center · Updated on 2024-05-09
10
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
M
Medical Center Haaglanden
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.
CONDITIONS
Official Title
SGM-101 in Colorectal Brain Metastases.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age over 18 years
- Women of childbearing potential and all males must use effective contraception during the study and for at least 30 days after the last dose
- Ability to communicate well in Dutch and willingness to follow study restrictions
- Diagnosed with brain metastasis of colorectal origin and scheduled for surgical removal
You will not qualify if you...
- History of any anaphylactic reaction
- Previous use of SGM-101
- Other active malignancies or cancer diagnosed in the last 5 years, except treated in situ cervical carcinoma or basal/squamous skin carcinoma
- Laboratory abnormalities: liver enzymes above 5 times normal, total bilirubin above 2 times normal, serum creatinine above 1.5 times normal, platelet count below 100 x 10^9/L, hemoglobin below 4 mmol/L (females) or 5 mmol/L (males)
- Positive test for HIV, hepatitis B surface antigen, or hepatitis C antibody, or untreated serious infections
- Pregnant or breastfeeding
- Any condition that may jeopardize patient well-being or study objectives according to the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
2
Medical Center Haaglanden
The Hague, Netherlands, 2512 VA
Actively Recruiting
Research Team
M
Mats Warmerdam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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