RecruitingNCT0589176918FCHUpdated Jun 24, 2026

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

A Phase 2/3 interventional study of 18Fluorocholine in Parathyroid Adenoma, sponsored by Andrei Iagaru. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Andrei Iagaru · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Parathyroid Adenoma

Browse trials for

Parathyroid Neoplasms 57

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
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.
Drug: 18Fluorocholine

Interventions

Drug18Fluorocholine
18F Fluorocholine 5 mCi ± 20% administered intravenously.

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

Stanford Hospital and Clinics
Stanford, California 94305, United States
- Meredith Durbahn · Contact · mdurbahn@stanford.edu
- Andrei Iagaru, MD · Principal investigator
Recruiting

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 11801711 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT05891769
Lead sponsor: Andrei Iagaru
Responsible party: Andrei Iagaru (Professor of Radiology (Nuclear Medicine), Stanford University) — Sponsor-investigator
First posted: Jun 7, 2023
Start date: Sep 27, 2023
Primary completion: Jul 1, 2027 (estimated)
Completion: Jul 1, 2028 (estimated)
Last update: Jun 24, 2026

Study contacts

Andrea Otte, DPT

Contact

anotte@stanford.edu

650-736-4183

Andrei Iagaru, MD

study director · Stanford University

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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