Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04755920
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2021-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SGM-101 in Colorectal Brain Metastases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-14', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases.', 'timeFrame': 'Intraoperative', 'description': '* Concordance between the fluorescent signal and the tumor status (incl. degree of CEA-expression) of resected tissue;\n* Concordance between the fluorescent signal and the resection margin with the use of neuronavigation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Neoplasms', 'Rectum Cancer', 'Colorectal Neoplasms', 'Brain Metastases', 'Brain Neoplasms', 'Brain Diseases', 'Brain Cancer', 'Brain Tumor', 'Intestinal Neoplasms', 'Gastrointestinal Neoplasms', 'Gastrointestinal Cancer', 'Gastrointestinal Disease', 'Intestinal Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed informed consent prior to any study-mandated procedure;\n2. Patients aged over 18 years old;\n3. 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.\n4. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.\n5. Diagnosed with brain metastasis of colorectal origin and scheduled for a resection.\n\nExclusion Criteria:\n\n1. History of any anaphylactic reaction;\n2. Previous use of SGM-101;\n3. 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;\n4. Laboratory abnormalities defined as:\n\n 1. Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the or;\n 2. Total bilirubin above 2 times the ULN or;\n 3. Serum creatinine above 1.5 times the ULN or;\n 4. Platelet count below 100 x 109/L or;\n 5. Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males);\n 6. 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;\n5. Patients pregnant or breastfeeding;\n6. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives."}, 'identificationModule': {'nctId': 'NCT04755920', 'acronym': 'SGM-CBM', 'briefTitle': 'SGM-101 in Colorectal Brain Metastases.', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'A Feasibility Study of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Intraoperative Detection of Colorectal Brain Metastases.', 'orgStudyIdInfo': {'id': 'NL74956.058.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with colorectal brain metastases', 'description': '10 mg SGM-101, administration 3 to 5 days prior to surgery.', 'interventionNames': ['Drug: SGM-101']}], 'interventions': [{'name': 'SGM-101', 'type': 'DRUG', 'description': 'Fluorescence-guided surgery', 'armGroupLabels': ['Patients with colorectal brain metastases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Alexander Vahrmeijer, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '2512 VA', 'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marike Broekman, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Medical Center Haaglanden', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'centralContacts': [{'name': 'Mats Warmerdam, MD', 'role': 'CONTACT', 'email': 'm.i.warmerdam@lumc.nl', 'phone': '+31 71 5265 401'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Center Haaglanden', 'class': 'OTHER'}, {'name': 'Surgimab', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Oncologic Surgeon - Hepatobiliary and Colorectal', 'investigatorFullName': 'Alexander Vahrmeijer', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}