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

NCT05891769 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 68169
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 1 hour

Study Arms (1)

18FCH PET/CT

EXPERIMENTAL

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

18Fluorocholine DRUG

18F Fluorocholine 5 mCi ± 20% administered intravenously.

18FCH PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrei Iagaru: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Parathyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases

Study Officials

• Andrei Iagaru, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Andrea Otte, DPT

CONTACT

650-736-4183; anotte@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology (Nuclear Medicine)

Model Details: This is a prospective, single-center, single-arm study enrolling 100 adult participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)