CEA for the delineation of primary and recurrent tumor and metastases in patients undergoing curative surgery for colorectal cancer

  • STATUS
    Recruiting
  • participants needed
    30
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Updated on 19 February 2024

Summary

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

Description

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.

FAQ


Details
Condition colorectal cancer,oncology
Age 99years or below
Clinical Study Identifier03659448
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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