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Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases

NCT06371339 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-06

No results posted yet for this study

Summary

This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.

Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population.

20 patients will be included in the study.

Conditions

  • Hyperthyroidism

Interventions

DEVICE

Additional acquisitions with the investigational gamma-camera " MoTI ".

The gamma-camera MoTI will be used for the study to carry out 3 or 4 additional acquisitions (depending on the therapeutic indication) compared with those provided for in standard practice with a conventional gamma camera (Syngula). Patients will receive their treatment as usual in two stages: * 1/ Pre-therapy phase: 1. Administration of a tracer dose of 131I (Day 0). 2. Assessment of 131I uptake/fixation rate at Day 0, Day 1, Day 5. 3. Determination of the therapeutic dose of 131I to be administered to the patient after collegial discussion. * 2/ Therapy phase: 1. Administration of the therapeutic dose (Day 0). 2. Thyroid scintigraphy within 4 hours of treatment before the patient returns home (Day 0). For the study, scintigraphic acquisitions will be carried out respectively using both the standard gamma camera Syngula and the gamma camera MoTI.

Sponsors & Collaborators

  • Laboratoire IJCLab

    collaborator UNKNOWN

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2025-05-27
Completion
2025-05-27

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371339 on ClinicalTrials.gov