CEA for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer
Brief description of study
SGM-101 is a fluorochrome-labeled anti-carcino-embryonic antigen (CEA) monoclonal
antibody. What this means is that part of SGM-101 is a chemical that is attracted to and
will attach to the cells of your cancer. Another part of SGM-101 is a chemical that will
glow when infrared light is shined on it. Infrared light is a low energy part of normal light
such as sunlight, but it is invisible to our eyes.
The purposes of this study are to test the effectiveness of the study drug, SGM-101 to
allow the doctor who will perform the surgery to remove your cancer to see better which
tissue is cancer and which is healthy so that the surgery can be performed more precisely
to get all the cancer tissue and as little healthy tissue as possible. The safety of SGM-101
will also be studied and you will be followed closely to see if there are any side effects
(“adverse events”).
SGM-101 is an experimental drug, not approved by the Food and Drug Administration
(“FDA”), and this study is being performed to see if it works as expected, is safe to use,
and, if so, whether it may be approved by FDA to be used regularly. But at this time
SGM-101 is an experimental drug that has not been conclusively proven to have a benefit
in humans
Detailed description of study
Patients will be assigned to one group or the other based upon the location in your body of your cancer, whether your cancer is new or has returned, and whether you live in the United States or Europe. Other than these factors, the assignment will be determined only by chance (randomization) and neither you, the study doctor, nor SurgiMab, the study sponsor, will decide to which group you will be assigned. Patients will be assigned to one group or the other following the completion of all screening assessments and after confirmation of their eligibility So you will not know whether or not you will receive SGM-101 when you agree to participate in the study, but you will be told prior to your surgery if you will receive it.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
colorectal cancer,oncology
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Age: - 99 Years
-
Gender: All
Updated on
19 Feb 2020.
Study ID: 831268
