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

April 12, 2024 updated by: Institut Claudius Regaud

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients with hyperthyroidism treated and monitored according to the standard practices.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The clinical feasibility of using an ambulatory gamma camera.
Time Frame: Maximum 1 month for each patient.

Clinical feasibility will be assessed according to the following dimensions:

  1. 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").
  2. 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of acceptance of the gamma camera by operators for carrying out examinations
Time Frame: Maximum 1 month for each patient.
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.
The quality of the images for the expected clinical use
Time Frame: Maximum 1 month for each patient.
The quality will be assessed using a Likert scale from 1 (Not Interpretable) to 5 (Fully Interpretable).
Maximum 1 month for each patient.
The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS)
Time Frame: Maximum 1 month for each patient.
It will be assessed using a Likert scale of 1 (Totally incompatible) and 5 (Totally compatible).
Maximum 1 month for each patient.
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)
Time Frame: Maximum 1 month for each patient.
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.
The 131I fixation rates will be measured in percent at different times.
Time Frame: Maximum 1 month for each patient.
Maximum 1 month for each patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Laboratoire IJCLab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 VADS 03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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