NCT05713123

Brief Summary

The aim of this study is to show that the SPECT/CT whole body recording procedure lasting less than or equal to 30 minutes in a VERITON-CT™ camera, can be substituted for the classic procedure, giving at least equivalent information in searches for primary or metastatic neoplastic lesions.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 6, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

December 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2025

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

December 6, 2022

Last Update Submit

June 18, 2024

Conditions

Device

Keywords

Iodine 131Thyroid cancerCamera CZT (cadmium-Zinc-Tellurid)

Outcome Measures

Primary Outcomes (1)

  • Compare post-therapy imaging performed with the two procedures

    Type of lesions * Lesions * The nature of the lesion(s): thyroid residue and/or lymph node lesion and/or metastases (distant lesions). * Number of lesions in conventional camera and in VERITON-CT™ camera.

    18 months

Secondary Outcomes (3)

  • Compare the two procedures in terms of cancer status result.

    18 months

  • Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera

    18 months

  • Evaluate the two exams in terms of ergonomics for technologists

    18 months

Study Arms (1)

Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq)

EXPERIMENTAL

The study will be offered to patients suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq). When they come in nuclear medicine to have the iodine scan in Anger's camera, if they signed the consent, they will the SPECT/CT whole body in VERITON-CT camera

Other: A SPECT-CT whole body is added in VERITON-CT camera

Interventions

A SPECT-CT whole body is added in VERITON-CT cameraOTHER

A SPECT-CT whole body in VERITON-CT camera is added after the conventional procedure recorded in Anger camera

Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18, who have understood and signed the informed consent form.
  • Person suffering from thyroid cancer and for whom the multidisciplinary meeting has validated a treatment by iodine 131 (1100 MBq or 3700 MBq).
  • Person with no contraindication to carrying out the examination.
  • Person affiliated to a social security scheme.

You may not qualify if:

  • Person with a known allergy to one of the components of the radiopharmaceutical (Iodine 131 capsule).
  • Pregnant woman or woman of childbearing age and without suitable contraceptive means, or breastfeeding mother.
  • Person whose medical condition is unstable and/or unable to remain still in the supine position during recordings.
  • Person deprived of liberty by a judicial or administrative decision.
  • Person of full age subject to a measure of legal protection (guardianship, curators, safeguard of justice).
  • Adult person unable to express his consent and who is not the subject of a legal protection measure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Elodie CHEVALIER, MD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique ROCH, MSc

CONTACT

0383154276v.roch@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patients received Iode 131 for thyroid cancer and 72 hours after taking iodine capsule,
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 6, 2022

First Posted

February 6, 2023

Study Start

December 26, 2022

Primary Completion

December 26, 2024

Study Completion

April 26, 2025

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

FR(1)