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

NCT ID: NCT06371339

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2025-05-27

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Patients with hyperthyroidism treated and monitored according to the standard practices.

Group Type: OTHER

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. Patient with hyperthyroidism (Graves' disease, toxic nodular goiter (TNG) or toxic multi hetero nodular goiter (GMHNT)) relevant to an indication for 131I treatment.

3. Patient with no risk of iodine saturation.

4. Patient able to maintain a sitting position in an armchair for 10 minutes with chin raised and held by a "chin rest" with head in extension.

5. WHO index ≤ 1.

6. For non-menopausal patients, use of an effective contraceptive method at the start of the clinical investigation and throughout the clinical investigation, and a negative pregnancy test before administration of the tracer activity and the 131I therapeutic activity.

7. Patient signed informed consent prior to inclusion in the clinical investigation and prior to any specific procedure for the clinical investigation.

8. Patient affiliated to a social security scheme in France.

Exclusion Criteria

1. Absence of clinical or biological hyperthyroidism.

2. Patient with a contraindication to 131I treatment.

3. Existence of one or more nodule(s) associated with hyperthyroidism at risk of malignancy according to EU-TIRADS and Bethesda criteria if cytopuncture performed.

4. Active orbithopathy associated with Graves' disease.

5. Contrast-enhanced examination performed within the two months prior to inclusion.

6. Use of iodised products for skin disinfection (Betadine) in the 4 weeks prior to inclusion.

7. Treatment with Amiodarone and derivatives in the 18 months prior to inclusion. (Ioduria test to rule out iodine saturation).

8. Pregnant or breast-feeding woman.

9. Patient planning pregnancy within 6 months of 131I treatment.

10. Any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical monitoring and/or procedures set out in the clinical investigation protocol.

11. Any co-existing medical condition which, in the opinion of the investigator, could constitute a risk by participating in this study.

12. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire IJCLab

UNKNOWN

Sponsor Role: collaborator

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IUCT-O

Toulouse, , France

Countries

France

Other Identifiers

23 VADS 03

Identifier Type: -

Identifier Source: org_study_id