Thyroid Uptake Quantification Validation on a Three-dimen... | NCT07610460

Studies
Thyroid Uptake Quantification Validation on a Three-dimensional (3D) Cadmium-Zinc-Telluride (CZT) New Generation Gamma Camera

NCT07610460

Sponsor

Centre Hospitalier Princesse Grace

Status

Completed

Last Update Posted

May 28, 2026Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Hypo or Hyperthyroidism

Interventions

No Intervention: Observational Cohort

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

May 2026

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 1, 2025Actual

Primary Completion Date

Mar 31, 2026Actual

Completion Date

Mar 31, 2026Actual

First Submitted Date

May 15, 2026

First Submission Date that Met QC Criteria

May 22, 2026

First Posted Date

May 28, 2026Actual

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

May 22, 2026

Last Update Posted Date

May 28, 2026Actual

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

Thyroid scintigraphy using technetium-99m (99mTc) pertechnetate is traditionally performed using planar imaging to estimate thyroid uptake. Recent developments in quantitative SPECT/CT allow direct activity quantification from three-dimensional tomographic acquisitions. The aim of this study was to evaluate the accuracy of thyroid uptake quantification obtained from 3D SPECT/CT compared with conventional planar image.

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.

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

27Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention: Observational Cohort	Other	Planar and SPECT/CT acquisitions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantification of thyroid uptake on a 3D CZT gamma camera		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hypothyroidism
hyperthyroidism

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

No selection it's 27 consecutive patients

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
37522931	Background	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.
33008929

ID	Term
D006980	Hyperthyroidism
D013959	Thyroid Diseases