Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05891769
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010282', 'term': 'Parathyroid Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, single-center, single-arm study enrolling 100 adult participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of lesions detected by PET/CT for detecting parathyroid adenomas.', 'timeFrame': 'up to 1 hour', 'description': 'Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parathyroid Adenoma']}, 'referencesModule': {'references': [{'pmid': '22310246', 'type': 'BACKGROUND', 'citation': 'Ciappuccini R, Morera J, Pascal P, Rame JP, Heutte N, Aide N, Babin E, Reznik Y, Bardet S. Dual-phase 99mTc sestamibi scintigraphy with neck and thorax SPECT/CT in primary hyperparathyroidism: a single-institution experience. Clin Nucl Med. 2012 Mar;37(3):223-8. doi: 10.1097/RLU.0b013e31823362e5.'}, {'pmid': '28121522', 'type': 'BACKGROUND', 'citation': 'Kluijfhout WP, Pasternak JD, Gosnell JE, Shen WT, Duh QY, Vriens MR, de Keizer B, Hope TA, Glastonbury CM, Pampaloni MH, Suh I. 18F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study. Radiology. 2017 Aug;284(2):460-467. doi: 10.1148/radiol.2016160768. Epub 2017 Jan 25.'}, {'pmid': '33674400', 'type': 'BACKGROUND', 'citation': 'Hope TA, Graves CE, Calais J, Ehman EC, Johnson GB, Thompson D, Aslam M, Duh QY, Gosnell JE, Shen WT, Roman SA, Sosa JA, Kluijfhout WP, Seib CD, Villaneuva-Meyer JE, Pampaloni MH, Suh I. Accuracy of 18F-Fluorocholine PET for the Detection of Parathyroid Adenomas: Prospective Single-Center Study. J Nucl Med. 2021 Nov;62(11):1511-1516. doi: 10.2967/jnumed.120.256735. Epub 2021 Mar 5.'}, {'pmid': '34301418', 'type': 'BACKGROUND', 'citation': 'Graves CE, Hope TA, Kim J, Pampaloni MH, Kluijfhout W, Seib CD, Gosnell JE, Shen WT, Roman SA, Sosa JA, Duh QY, Suh I. Superior sensitivity of 18F-fluorocholine: PET localization in primary hyperparathyroidism. Surgery. 2022 Jan;171(1):47-54. doi: 10.1016/j.surg.2021.05.056. Epub 2021 Jul 21.'}, {'pmid': '11801711', 'type': 'BACKGROUND', 'citation': 'DeGrado TR, Reiman RE, Price DT, Wang S, Coleman RE. Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. J Nucl Med. 2002 Jan;43(1):92-6.'}]}, 'descriptionModule': {'briefSummary': 'This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)\n2. Negative or equivocal 99mTc Sestamibi SPECT/CT\n3. Able to provide written consent\n4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN\n6. Karnofsky performance status of \\>50 (or ECOG/WHO equivalent)\n7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.\n\nExclusion Criteria:\n\n1. Less than 18 years old at the time of radiotracer administration\n2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\< 60 mL/min or serum creatinine \\>1.5 x ULN\n3. QTcF \\>470 msec on electrocardiogram (ECG) or congenital long QT syndrome'}, 'identificationModule': {'nctId': 'NCT05891769', 'acronym': '18FCH', 'briefTitle': '99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT', 'orgStudyIdInfo': {'id': '68169'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18FCH PET/CT', 'description': 'Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area.', 'interventionNames': ['Drug: 18Fluorocholine']}], 'interventions': [{'name': '18Fluorocholine', 'type': 'DRUG', 'description': '18F Fluorocholine 5 mCi ± 20% administered intravenously.', 'armGroupLabels': ['18FCH PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meredith Durbahn', 'role': 'CONTACT', 'email': 'mdurbahn@stanford.edu'}, {'name': 'Andrei Iagaru, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Andrea Otte, DPT', 'role': 'CONTACT', 'email': 'anotte@stanford.edu', 'phone': '650-736-4183'}], 'overallOfficials': [{'name': 'Andrei Iagaru, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrei Iagaru', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology (Nuclear Medicine)', 'investigatorFullName': 'Andrei Iagaru', 'investigatorAffiliation': 'Stanford University'}}}}