Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT05472493
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is diagnostic test accuracy (expressed as sensitivity, specificity, positive predictive value, and negative predictive value) for CETO PET/CT using adrenal vein sampling as a reference standard.', 'timeFrame': 'It will be measured using adrenal vein sampling approximately the same time as the CETO PET/CT.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Aldosteronism']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\\[18F\\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard.', 'detailedDescription': 'This is a phase II study (with targeted recruitment of 30 participants) designed to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\\[18F\\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard. Subjects consenting to study participation will receive the \\[18-F\\] CETO followed by the PET/CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with hypertension\n* Individuals with an elevated screening adrenal renin ratio (ARR)\n* Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ or plus a discrete adrenal nodule or nodules (1 cm or greater) with concordant lateralization on AVS.\n\nExclusion Criteria:\n\n* Individuals with chronic kidney disease (estimated glomerular filtration rate \\<40 mL/min/1.73m2),\n* Individuals with a history of uncontrolled severe hypertension (\\>180/110 mmHg), severe uncontrolled diabetes, suspected or proven hypercortisolism (e.g., cortisol-secreting adrenal adenoma), or individuals with an anatomical disease of the liver (e.g., hepatic adenoma or focal nodular hyperplasia)\n* Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.\n* Pregnancy, lactation, and pheochromocytoma.'}, 'identificationModule': {'nctId': 'NCT05472493', 'briefTitle': 'Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism', 'orgStudyIdInfo': {'id': 'REB22-0772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CETO', 'description': 'The consented participants will receive the \\[18-F\\] CETO through the IV and a PET/CT scan afterwards.', 'interventionNames': ['Biological: [18-F]CETO']}], 'interventions': [{'name': '[18-F]CETO', 'type': 'BIOLOGICAL', 'description': 'PET/CT will be performed; Non-contrast CT images will be acquired over the adrenals (slice width, \\~3 mm). CETO (\\~2.5 MBq/kg; up to 365 MBq +/- 20%) will be administered as a single dose intravenously and dynamic PET images will be acquired from \\~0-90 minutes.', 'armGroupLabels': ['CETO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Alexander Leung, MD', 'role': 'CONTACT', 'email': 'aacleung@ucalgary.ca', 'phone': '(403) 955-8358'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Alexander Leung, MD', 'role': 'CONTACT', 'email': 'aacleung@ucalgary.ca', 'phone': '(403) 955-8358'}], 'overallOfficials': [{'name': 'Alexander Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}