SGM-101 in Colorectal Lung Metastases

  • STATUS
    Recruiting
  • End date
    Dec 1, 2021
  • participants needed
    10
  • sponsor
    Leiden University Medical Center
Updated on 13 February 2021

Summary

Near-infrared fluorescence-guided oncologic surgery (FGOS) with the use of a tumor specific tracer (SGM-101) developed by Surgimab can provide valuable intra-operative information about tumor location and extensiveness. SGM-101 already proven to be safe and valuable in colorectal cancer.

This study aims to prove feasibility for colorectal lung metastases.

Details
Condition Colorectal Cancer, Rectal disorder, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, Metastatic Colon Cancer, colorectal neoplasm, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment SGM-101
Clinical Study IdentifierNCT04737213
SponsorLeiden University Medical Center
Last Modified on13 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: colorectal cancers or colorectal neoplasm or Colon cancer; rectal cancer or Metastatic Colon Cancer or Colorectal Cancer or colorectal tumor or cancer...?
Signed informed consent prior to any study-mandated procedure
Patients aged over 18 years old
All women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment
Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions
Diagnosed with lung metastasis of colorectal origin and scheduled for a resection

Exclusion Criteria

History of any anaphylactic reaction
Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma
Laboratory abnormalities defined as
Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or
Total bilirubin above 2 times the ULN or
Serum creatinine above 1.5 times the ULN or
Platelet count below 100 x 109/L or
Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males)
Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections
Patients pregnant or breastfeeding (pregnancy should be ruled out by a pregnancy test within two weeks prior to administration of the conjugate)
Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives
Previous SGM-101 use
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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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