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NCT Number: NCT05891769

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Andrei Iagaru, MD

PRINCIPAL_INVESTIGATOR

Meredith Durbahn

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18Fluorocholine

Drug

18F Fluorocholine 5 mCi ± 20% administered intravenously.

Primary outcomes

  1. Number of lesions detected by PET/CT for detecting parathyroid adenomas.

    Time frame: up to 1 hour

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Otte, DPT

CONTACT

[email protected]

650-736-4183

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Registry information

Official study title

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

Acronym: 18FCH

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 7, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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