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

• Sponsor: Andrei Iagaru (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05891769
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 48

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Parathyroid Adenoma	Drug: 18Fluorocholine	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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; 18F Fluorocholine 5 mCi ± 20% administered intravenously.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Andrei Iagaru

Investigators

• Study Director: Andrei Iagaru, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Andrei Iagaru, Professor of Radiology (Nuclear Medicine), Stanford University
• ClinicalTrials.gov Identifier: NCT05891769
• Other Study ID Numbers: 68169
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Adenoma; Parathyroid Neoplasms

Study Results

No Results Posted as of Jun 7, 2023