Dual-phase 99mTc sestamibi scintigraphy with neck and thorax SPECT/CT in primary hyperparathyroidism: a single-institution experience.
Renaud Ciappuccini, Julia Morera, Pierre Pascal...
https://pubmed.ncbi.nlm.nih.gov/22310246Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID05891769
Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
Led by Andrei Iagaru · Updated on 2025-09-10
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a PET imaging method with Fluorine-18 bound to Choline to detect parathyroid adenomas in participants who have elevated calcium and abnormal parathyroid hormone levels but whose standard 99mTc Sestamibi SPECT/CT scans are negative or unclear. This single-center, single-arm trial focuses on improving detection of suspected parathyroid adenomas. Participants will receive an intravenous injection of 18F Fluorocholine at a dose of 5 mCi ± 20%. About 45 to 60 minutes after the injection, they will undergo a low-dose CT scan from the skull base to mid thighs, followed by a static PET emission scan over the same region. The study does not use a comparison group or placebo. During the study, researchers will monitor the number of parathyroid lesions detected by PET/CT within one hour after imaging. Participants will be assessed for liver and kidney function, and their physical status will be evaluated. Safety monitoring includes checking heart rhythm and confirming pregnancy status for women. The trial is expected to continue until July 2027, and participants will be closely observed during and shortly after the imaging procedure.
CONDITIONS
Brief Title
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Suspected parathyroid adenoma with elevated serum calcium and normal or high parathyroid hormone levels
- Negative or equivocal 99mTc Sestamibi SPECT/CT scan
- Able to provide written consent
- Total bilirubin less than or equal to 1.5 times the upper limit of normal
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than or equal to 5 times the upper limit of normal
- Karnofsky performance status greater than 50 (or equivalent ECOG/WHO status)
- Women must not be pregnant according to radiology imaging policies
You will not qualify if you...
- Younger than 18 years at the time of radiotracer administration
- Creatinine clearance below 60 mL/min or serum creatinine greater than 1.5 times the upper limit of normal
- QTcF interval greater than 470 msec on ECG or congenital long QT syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 hour
Participants receive an intravenous injection of 18F Fluorocholine, followed by a low dose CT scan and a static PET emission scan approximately 45-60 minutes later.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Actively Recruiting
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Research Team
A
Andrea Otte, DPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
18F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study.
Wouter P Kluijfhout, Jesse D Pasternak, Jessica E Gosnell...
https://pubmed.ncbi.nlm.nih.gov/28121522Accuracy of 18F-Fluorocholine PET for the Detection of Parathyroid Adenomas: Prospective Single-Center Study.
Thomas A Hope, Claire E Graves, Jeremie Calais...
https://pubmed.ncbi.nlm.nih.gov/33674400Superior sensitivity of 18F-fluorocholine: PET localization in primary hyperparathyroidism.
Claire E Graves, Thomas A Hope, Jina Kim...
https://pubmed.ncbi.nlm.nih.gov/34301418Pharmacokinetics and radiation dosimetry of 18F-fluorocholine.
Timothy R DeGrado, Robert E Reiman, David T Price...
https://pubmed.ncbi.nlm.nih.gov/11801711