Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2023-09-27
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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18FCH PET/CT
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.
18Fluorocholine
18F Fluorocholine 5 mCi ± 20% administered intravenously.
Interventions
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18Fluorocholine
18F Fluorocholine 5 mCi ± 20% administered intravenously.
Eligibility Criteria
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Inclusion Criteria
2. Negative or equivocal 99mTc Sestamibi SPECT/CT
3. Able to provide written consent
4. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
6. Karnofsky performance status of \>50 (or ECOG/WHO equivalent)
7. Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
Exclusion Criteria
2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 60 mL/min or serum creatinine \>1.5 x ULN
3. QTcF \>470 msec on electrocardiogram (ECG) or congenital long QT syndrome
18 Years
ALL
No
Sponsors
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Andrei Iagaru
OTHER
Responsible Party
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Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Principal Investigators
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Andrei Iagaru, MD
Role: STUDY_DIRECTOR
Stanford University
Locations
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Stanford Hospital and Clinics
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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68169
Identifier Type: -
Identifier Source: org_study_id
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