NCT05049551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

September 9, 2021

Last Update Submit

September 9, 2021

Conditions

Keywords

thyroiduptakequantificationCZTPlanarSPECT/CT

Outcome Measures

Primary Outcomes (1)

  • Thyroid uptake

    Quantification of thyroid uptake

    Inclusion

Secondary Outcomes (1)

  • SPECT/CT

    Inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty-three consecutive participants referred in our nuclear medicine department for hyperthyroidism

You may qualify if:

  • Hyperthyroidism confirmed by blood test (TSH) and thyroid ultrasound

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Related Publications (5)

  • 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.

    PMID: 21484383BACKGROUND
  • 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.

    PMID: 28096891BACKGROUND
  • 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.

    PMID: 31392371BACKGROUND
  • 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.

    PMID: 33008929BACKGROUND
  • 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.

MeSH Terms

Conditions

HyperthyroidismThyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2021

First Posted

September 20, 2021

Study Start

October 30, 2019

Primary Completion

June 22, 2020

Study Completion

September 7, 2020

Last Updated

September 20, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations