- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07610460
Thyroid Uptake Quantification Validation on a Three-dimensional (3D) Cadmium-Zinc-Telluride (CZT) New Generation Gamma Camera (QThy2Dvc3D)
Clinical Evaluation of Thyroid Uptake Quantification With Technetium-99m (99mTc)-Pertechnetate: Comparison Between Gold Standard Planar and Quantitative 3D CZT Single Photon Emission Computed Tomography/Cumputed Tomography (SPECT/CT) Scintigraphy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Planar and SPECT/CT scintigraphy will be performed on a new generation 3D CZT gamma camera and thyroid uptake (TU) value will be calculated on planar acquisition for 27 consecutive patients referred in the department of the investigators for hyper or hypothyroidism.
With a quantitative approach using attenuation, scatter correction and iterative algorithm (12 iterations and 8 subsets) with post filter Median Full Width at Half Maximum (FWHM=3), the TU value with SPECT or SPECT/CT acquisitions can be calculate.
The objective will be to evaluate the potential of a new 3D CZT gamma camera to estimate the thyroid uptake on SPECT (Tomography without attenuation correction) and SPECT/CT (tomography with attenuation correction) acquisitions compared with standard planar scintigraphy as a gold standard.
To established this study it will be necessary to introduce cross-calibration factors performed from homogeneous phantoms, for planar and 3D SPECT acquisitions, to estimate the thyroid uptake values.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Monaco, Monaco, 98000
- Centre Hospitalier Princesse Grace
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- hypothyroidism
- hyperthyroidism
Exclusion Criteria:
- Pregnant women
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quantification of thyroid uptake on a 3D CZT gamma camera
Time Frame: Day 1
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Day 1
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Collaborators and Investigators
Publications and helpful links
General Publications
- Ritt P, Vija H, Hornegger J, Kuwert T. Absolute quantification in SPECT. Eur J Nucl Med Mol Imaging. 2011 May;38 Suppl 1:S69-77. doi: 10.1007/s00259-011-1770-8. Epub 2011 Apr 12.
- Gnesin S, Leite Ferreira P, Malterre J, Laub P, Prior JO, Verdun FR. Phantom Validation of Tc-99m Absolute Quantification in a SPECT/CT Commercial Device. Comput Math Methods Med. 2016;2016:4360371. doi: 10.1155/2016/4360371. Epub 2016 Dec 14.
- Giovanella L, Avram AM, Iakovou I, Kwak J, Lawson SA, Lulaj E, Luster M, Piccardo A, Schmidt M, Tulchinsky M, Verburg FA, Wolin E. EANM practice guideline/SNMMI procedure standard for RAIU and thyroid scintigraphy. Eur J Nucl Med Mol Imaging. 2019 Nov;46(12):2514-2525. doi: 10.1007/s00259-019-04472-8. Epub 2019 Aug 7.
- Mariani G, Tonacchera M, Grosso M, Orsolini F, Vitti P, Strauss HW. The Role of Nuclear Medicine in the Clinical Management of Benign Thyroid Disorders, Part 1: Hyperthyroidism. J Nucl Med. 2021 Mar;62(3):304-312. doi: 10.2967/jnumed.120.243170. Epub 2020 Oct 2.
- Serrano B, Amblard R, Beaumont T, Hugonnet F, Dietz M, Berthier F, Garnier N, Villeneuve R, Nataf V, Mocquot F, Montemagno C, Faraggi M, Paulmier B. Quantitative analysis of 99mTc-pertechnetate thyroid uptake with a large-field CZT gamma camera: feasibility and comparison between SPECT/CT and planar acquisitions. EJNMMI Phys. 2023 Jul 31;10(1):45. doi: 10.1186/s40658-023-00566-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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