Thyroid Uptake Quantification on a New Generation of Gamm... | NCT05049551

Studies
Thyroid Uptake Quantification on a New Generation of Gamma Camera

NCT05049551

Sponsor

Centre Hospitalier Princesse Grace

Status

Completed

Last Update Posted

Sep 20, 2021Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Hyperthyroidism

Interventions

Not provided

Countries

Monaco

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2019Actual

Primary Completion Date

Jun 22, 2020Actual

Completion Date

Sep 7, 2020Actual

First Submitted Date

Sep 9, 2021

First Submission Date that Met QC Criteria

Sep 9, 2021

First Posted Date

Sep 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2021

Last Update Posted Date

Sep 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thyroid uptake	Quantification of thyroid uptake	Inclusion

Secondary Outcomes

Measure	Description	Time Frame
SPECT/CT	Diagnostic contribution of SPECT/CT	Inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hyperthyroidism confirmed by blood test (TSH) and thyroid ultrasound

Exclusion Criteria:

Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Princesse Grace		Monaco		98000	Monaco

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21484383	Background	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.
28096891	Background	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.

ID	Term
D006980	Hyperthyroidism
D013959	Thyroid Diseases