Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02629003
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[11C]Cimbi-36 Dosimetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C586246', 'term': 'Cimbi-36'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective dose and absorbed dose for selected organs', 'timeFrame': '0 - 120 minutes', 'description': 'Based on the Positron Emission Tomography (PET) scan Time activity curves (TACs) will be generated and used for calculating the radiation doses for selected organs and over all effective radiation dose.'}], 'secondaryOutcomes': [{'measure': 'Measurement of radioactive metabolites in plasma', 'timeFrame': '0 - 120 minutes', 'description': 'Venous blood samples will be used to measure radioactive metabolites and parent compound in the blood, using radio-High-performance liquid chromatography (HPLC). The parameters will be parent radioactivity and metabolite radioactivity as a fraction (unitless) of total radioactivity in plasma over time (unit = minutes).'}, {'measure': 'Measurement of radioactivity in plasma and whole blood', 'timeFrame': '0 - 120 minutes', 'description': 'Venous blood samples will be used to measure radioactivity in plasma and whole blood. The measurement will be given as a ratio (unitless) of plasma radioactivity relative to whole blood radioactivity over time (unit = minutes).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Positron Emission Tomography', 'Serotonin', '5-HT2A', 'Radioligand', 'Radiation dosimetry', 'Radiation dosage'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the dosimetry for the Positron Emission Tomography (PET) tracer \\[11C\\]Cimbi-36 in two different Carbon-11 labelling positions. This information will contribute to determining whether \\[11C\\]Cimbi-36 can be optimized by changing the C-11 labelling position.', 'detailedDescription': 'Healthy subjects wil undergo a whole-body Positron Emission Tomography (PET) scan with the Serotonin 2A Receptor (5-HT2A) radioligand \\[11C\\]Cimbi-36 or \\[11C\\]Cimbi-36-5 to determine the effective radiation dose and radiation dose for selected organs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* Signed informed consent\n\nExclusion Criteria:\n\n* Present or former neurological disease, severe somatic or psychiatric disease, or medication thet can interfere with the test results.\n* Pregnancy at the time of the scan\n* Breastfeeding\n* Alcohol or substance abuse\n* Exposure to radiation (\\>10 millisievert (mSv)) within the last year, or significant exposure at work\n* Allergy to any of the substances in the Investigational medicinal product (IMP) formulation'}, 'identificationModule': {'nctId': 'NCT02629003', 'briefTitle': '[11C]Cimbi-36 Dosimetry', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Evaluation of Radiation Dose for [11C]Cimbi-36', 'orgStudyIdInfo': {'id': 'H-15001910'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '[11C]Cimbi-36', 'description': '\\[11C\\]Cimbi-36\n\nMaximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)', 'interventionNames': ['Drug: [11C]Cimbi-36']}, {'type': 'ACTIVE_COMPARATOR', 'label': '[11C]Cimbi-36-5', 'description': '\\[11C\\]Cimbi-36-5\n\nMaximum of 600 Mega Becquerel (MBq) or 1.5 micrograms, single dose intravenous (I.V.)', 'interventionNames': ['Drug: [11C]Cimbi-36-5']}], 'interventions': [{'name': '[11C]Cimbi-36', 'type': 'DRUG', 'armGroupLabels': ['[11C]Cimbi-36']}, {'name': '[11C]Cimbi-36-5', 'type': 'DRUG', 'armGroupLabels': ['[11C]Cimbi-36-5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Neurobiology Research Unit, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Gitte M Knudsen, MD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurobiology Research Unit, Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gitte Moos Knudsen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair, Professor, MD, DMSc', 'investigatorFullName': 'Gitte Moos Knudsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}