Study on SGM-101 for Identifying Tumors and Metastases During Colorectal Cancer Surgery
Sponsor: Surgimab
ClinicalTrials ID:NCT03659448
This clinical trial is testing a new imaging agent, SGM-101, to see if it can better identify tumors and metastases during colorectal cancer surgery compared to the standard method using white light.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness of SGM-101, a special imaging agent used during surgery, in helping surgeons see primary and recurrent tumors and metastases in patients undergoing surgery for colorectal cancer. This will be compared to the usual method of using white light during surgery.
Description
This clinical trial is investigating the use of SGM-101, a new imaging agent that helps surgeons see cancerous tissues more clearly during surgery for colorectal cancer. SGM-101 is a special type of imaging agent that attaches to cancer cells, making them glow under a specific light. This study will compare how well SGM-101 works against the standard method of using regular white light to identify tumors and metastases during surgery. The trial is being conducted at multiple centers and involves patients who are undergoing surgery to remove colorectal cancer. The goal is to see if SGM-101 can improve the accuracy of identifying cancerous tissues, which may help in more effective removal of the cancer during surgery.
Eligibility Criteria
Inclusion Criteria
- Scheduled for surgery to remove colorectal cancer, including primary cT4 colon cancer, primary cT3/4 rectal cancer, recurrent colorectal cancer, or colorectal cancer that has spread to the peritoneum.
- Female patients must either be unable to have children (due to menopause or surgical procedures like tubal ligation or hysterectomy) or, if they can have children, must have a negative pregnancy test on the day of the injection and agree to use effective birth control for 30 days before and after the injection.
Exclusion Criteria
- Have other active cancers or have been diagnosed with another cancer in the last 5 years, except for certain treated skin cancers or cervical cancer.
- Have primary cancer of the appendix.
- Have abnormal lab results, such as high liver enzymes, high bilirubin, high creatinine, low neutrophil or platelet counts, or low hemoglobin levels.
- Test positive for HIV, hepatitis B, or hepatitis C, or have untreated serious infections.
- Have any condition that the study doctor believes could affect the patient's safety or the study's results.
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