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Recruiting NCT05891769

99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

Phase II / Phase III Interventional Parathyroid Adenoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18Fluorocholine.
Who it may be relevant to
Registry conditions: Parathyroid Adenoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT

Overview

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

Interventions

  • Drug 18Fluorocholine
    18F Fluorocholine 5 mCi ± 20% administered intravenously.

Primary outcome measures

  • Number of lesions detected by PET/CT for detecting parathyroid adenomas. [Time frame: up to 1 hour]

Eligibility criteria

Inclusion criteria

  • Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
  • Negative or equivocal 99mTc Sestamibi SPECT/CT
  • Able to provide written consent
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
  • Karnofsky performance status of >50 (or ECOG/WHO equivalent)
  • Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.

Exclusion criteria

  • Less than 18 years old at the time of radiotracer administration
  • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN
  • QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Hospital and Clinics — Stanford

Publications

  • 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 22310246
  • 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 28121522
  • 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 33674400
  • 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 34301418
  • 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. PMID 11801711

Identifiers

NCT: NCT05891769 · 68169

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗