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

Hyperthyroidism Clinical Trial

— THIDOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371339
• Other study ID #: 23 VADS 03
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Institut Claudius Regaud
• Contact: Slimane ZERDOUD
• Phone: 05 31 15 56 28
• Email: zerdoud.slimane[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. The camera will be used to measure the 131I uptake/fixation rates during the thyroid scintigraphy. 20 patients will be included in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hyperthyroidism
• Thyroid Diseases

Intervention

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: Administration of a tracer dose of 131I (Day 0). Assessment of 131I uptake/fixation rate at Day 0, Day 1, Day 5. Determination of the therapeutic dose of 131I to be administered to the patient after collegial discussion. 2/ Therapy phase: Administration of the therapeutic dose (Day 0). Thyroid scintigraphy and measurement of the 131I uptake rate within 4 hours of treatment. For the study, measurements of 131I uptake/fixation rates will be carried out using both the standard gamma camera Syngula and the gamma camera MoTI.

Locations

Country	Name	City	State
France	IUCT-O	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Laboratoire IJCLab

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clinical feasibility of using an ambulatory gamma camera.	Clinical feasibility will be assessed according to the following dimensions: Tolerability and acceptability of the gamma camera by the patient, assessed on a Likert scale between 1 (Not tolerated) and 5 (No discomfort) - (use of a "Patient Evaluation Questionnaire").; The quality of the images for the expected clinical use, assessed on a Likert scale from 1 (Not interpretable) to 5 (Totally Interpretable).; Success is defined as a patient for whom the tolerability and image production dimensions are >=3 for both examinations (Day 0 and Day 1 of the pre-therapy phase). A failure is defined as a patient presenting with at least one criterion <3 for one of the two examinations.	Maximum 1 month for each patient.
Secondary	The level of acceptance of the gamma camera by operators for carrying out examinations	The level will be assessed according to different dimensions: ergonomics, ease of handling, ease of installation, carrying out the examination and processing the examination. For each dimension, a Likert scale between 1 and 5 will be used (using a "Caregiver Evaluation Questionnaire").	Maximum 1 month for each patient.
Secondary	The quality of the images for the expected clinical use	The quality will be assessed using a Likert scale from 1 (Not Interpretable) to 5 (Fully Interpretable).	Maximum 1 month for each patient.
Secondary	The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS)	It will be assessed using a Likert scale of 1 (Totally incompatible) and 5 (Totally compatible).	Maximum 1 month for each patient.
Secondary	The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula)	The quality will be assessed using a Likert scale between 1 (Not at all satisfactory) and 5 (Very satisfactory).	Maximum 1 month for each patient.
Secondary	The 131I fixation rates will be measured in percent at different times.		Maximum 1 month for each patient.