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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05049551
Other study ID # 21-09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2019
Est. completion date September 7, 2020

Study information

Verified date September 2021
Source Centre Hospitalier Princesse Grace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake (TU) on Single photon emission computed tomography (SPECT) and SPECT/CT images in comparison with standard planar scintigraphy. The secondary objective is to analyze the diagnostic contribution of SPECT/CT imaging.


Description:

Planar and SPECT/CT scintigraphy will be performed on a new generation large field CZT gamma camera and thyroid uptake (TU) value will be calculated on planar acquisition for 23 consecutive patients referred in our department for hyperthyroidism. With a quantitative approach using attenuation, scatter correction and iterative algorithm with resolution recovery we will have the possibility to calculate the TU value with SPECT or SPECT/CT acquisitions. Our primary objective will be to evaluate the potential of a new large field 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. The secondary objective will be to analyze the diagnostic contribution of SPECT/CT images. To established this study it will be necessary to introduce cross-calibration factors performed from a thyroid phantom, for planar and SPECT acquisitions, to estimate the thyroid uptake values.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date September 7, 2020
Est. primary completion date June 22, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hyperthyroidism confirmed by blood test (TSH) and thyroid ultrasound Exclusion Criteria: - Pregnant women

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Monaco Centre Hospitalier Princesse Grace Monaco

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Princesse Grace

Country where clinical trial is conducted

Monaco, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Thyroid uptake Quantification of thyroid uptake Inclusion
Secondary SPECT/CT Diagnostic contribution of SPECT/CT Inclusion
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