Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT07099404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parathyroid Adenoma Detection With Rubidium-82 Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010282', 'term': 'Parathyroid Neoplasms'}, {'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615479', 'term': 'Rubidium-82'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake pattern of rubidium-82 in parathyroid adenomas', 'timeFrame': '3 months', 'description': 'Rudibium-82 uptake will be assessed using Maximum Standardized Uptake Value (SUVmax) and target-to-background ratios (TBR). TBR is calculated by dividing a lesion SUVmax by the mean SUV (SUVmean) or the blood pool. Maximum Standardized Uptake Value (SUVmax) and target-to-background (TBR) will be presented as median with interquartile range as well as minimum and maximum values.'}], 'secondaryOutcomes': [{'measure': 'Comparison between the uptakes of rubidium-82 and 18F-fluorocholine in patients with parathyroid adenomas', 'timeFrame': '3 months', 'description': 'Radioactive tracer uptake will be compared between Rudibium-82 and 18F-Fluorocholine. Uptake will be assessed using Maximum Standardized Uptake Value (SUVmax) and target-to-background ratios (TBR). TBR is calculated by dividing a lesion SUVmax by the mean SUV (SUVmean) or the blood pool. Maximum Standardized Uptake Value (SUVmax) and target-to-background (TBR) will be presented as median with interquartile range as well as minimum and maximum values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parathyroid adenomas, Rubidium-82'], 'conditions': ['Parathyroid Adenomas', 'Hyperparathyroidism, Primary']}, 'descriptionModule': {'briefSummary': 'Assess the uptake of rubidium-82 in parathyroid adenomas.', 'detailedDescription': 'Parathyroid adenomas demonstrate uptake of rubidium-82 chloride and can be detected with PET imaging.\n\nThe investigators aim to describe the uptake pattern of rubidium-82 chloride in parathyroid adenomas as well as compare the uptake pattern of rubidium-82 chloride to that of 18F-fluorocholine in patients with parathyroid adenoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 participants with a diagnosis of primary parathyroid adenoma who have previously undergone 18F-fluorocholine imaging will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18y\n2. Ability to undergo imaging logistics\n3. Ability to provide informed consent\n4. Biochemical evidence of primary hyperparathyroidism\n5. Documented parathyroid adenoma on prior 18F-fluorocholine imaging\n\nExclusion Criteria:\n\n1. Normocalcemic primary hyperparathyroidism\n2. Breastfeeding or pregnancy\n3. Claustrophobia or inability to undergo imaging logistics\n4. Any other history, condition, therapy, or uncontrolled intercurrent illness, which could in the opinion of the investigator affect compliance with study requirements or which would make the participant unsuitable for this study'}, 'identificationModule': {'nctId': 'NCT07099404', 'acronym': 'PARAGON', 'briefTitle': 'Parathyroid Adenoma Detection With Rubidium-82 Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Parathyroid Adenoma Detection With Rubidium Chloride Imaging: A Proof-of-Concept Study', 'orgStudyIdInfo': {'id': 'MP-33-2025-3547'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/CT imaging with rubidium-82', 'type': 'OTHER', 'otherNames': ['Rubidium-82', 'PET/CT'], 'description': 'PET imaging of the neck will be started immediately before infusion of 10 Megabecquerels per kilograms of rubidum-82 over 30 seconds. The acquisition will last 10 minutes. This will be followed by a non-contrast low-dose CT of the neck for localization and attenuation correction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Matthieu Pelletier-Galarneau, MD, MSc', 'role': 'CONTACT', 'email': 'matthieu.pelletier-galarneau@icm-mhi.org', 'phone': '514-376-3330', 'phoneExt': '4418'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Gad Abikhzer, MD', 'role': 'CONTACT', 'email': 'Gad.Abikhzer.med@ssss.gouv.qc.ca', 'phone': '514-340-8222'}], 'facility': 'Montreal Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Matthieu Pelletier-Galarneau, MD MSc', 'role': 'CONTACT', 'email': 'matthieu.pelletier-galarneau@icm-mhi.org', 'phone': '514-376-3330', 'phoneExt': '4418'}, {'name': 'Pelletier-Galarneau', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthieu Pelletier-Galarneau, MD MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of the Nuclear Medicine Department', 'investigatorFullName': 'Matthieu Pelletier-Galarneau, MD MSc', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}