Recruiting
Phase 2
Phase 3

99mTc Sestamibi vs. 18F Fluorocholine

Sponsor:

Andrei Iagaru

Code:

NCT05891769

Conditions

Parathyroid Adenoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18Fluorocholine

Study Details

Brief 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

Parathyroid Adenoma

Study ID

NCT05891769

Start date

Sep 27, 2023

Status verified date

Jun, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
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:

1. Less than 18 years old at the time of radiotracer administration
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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

18Fluorocholine

18F Fluorocholine 5 mCi ± 20% administered intravenously.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Andrea Otte, DPT

650-736-4183anotte@stanford.edu

Locations

Stanford Hospital and Clinics

Recruiting

Stanford, California, United States, 94305

Contacts

Meredith Durbahn

mdurbahn@stanford.edu

Principal Investigator:

Andrei Iagaru, MD

More Information

Sponsor

Andrei Iagaru

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrei Iagaru on 2026-06-24.