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

Primary Purpose

Parathyroid Adenoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
18Fluorocholine
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parathyroid Adenoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    18FCH PET/CT

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 26, 2023
    Last Updated
    May 26, 2023
    Sponsor
    Andrei Iagaru
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05891769
    Brief Title
    99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
    Acronym
    18FCH
    Official Title
    Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2026 (Anticipated)
    Study Completion Date
    July 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Andrei Iagaru

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parathyroid Adenoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    18FCH PET/CT
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    18Fluorocholine
    Intervention Description
    18F Fluorocholine 5 mCi ± 20% administered intravenously.
    Primary Outcome Measure Information:
    Title
    Number of lesions detected by PET/CT for detecting parathyroid adenomas.
    Description
    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
    Time Frame
    up to 1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Otte, DPT
    Phone
    650-736-4183
    Email
    anotte@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrei Iagaru, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22310246
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28121522
    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.
    Results Reference
    background
    PubMed Identifier
    33674400
    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.
    Results Reference
    background
    PubMed Identifier
    34301418
    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.
    Results Reference
    background
    PubMed Identifier
    11801711
    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.
    Results Reference
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    99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT

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