NCT06371339

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

Feasibility Study of a Gamma Camera for Optimizing Dosimetry of Patients With Thyroid Disease Treated With Radioactive Iodine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2024-04-17
• Last updated: 2025-08-06

Locations

1 site across 1 country: France