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

Parathyroid Adenoma Clinical Trial

— 18FCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891769
• Other study ID #: 68169
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 27, 2023
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Andrea Otte, DPT
• Phone: 650-736-4183
• Email: anotte[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Parathyroid Adenoma
• Parathyroid Neoplasms

Intervention

Drug:
• 18Fluorocholine
18F Fluorocholine 5 mCi ± 20% administered intravenously.

Locations

Country	Name	City	State
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrei Iagaru

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Erratum In: J Nucl Med 2002 Apr;43(4):509. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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