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Trial Title:
Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine
NCT ID:
NCT05713123
Condition:
Device
Conditions: Keywords:
Iodine 131
Thyroid cancer
Camera CZT (cadmium-Zinc-Tellurid)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Patients received Iode 131 for thyroid cancer and 72 hours after taking iodine capsule,
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
A SPECT-CT whole body is added in VERITON-CT camera
Description:
A SPECT-CT whole body in VERITON-CT camera is added after the conventional procedure
recorded in Anger camera
Arm group label:
Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq)
Summary:
The aim of this study is to show that the SPECT/CT whole body recording procedure lasting
less than or equal to 30 minutes in a VERITON-CT™ camera, can be substituted for the
classic procedure, giving at least equivalent information in searches for primary or
metastatic neoplastic lesions.
Detailed description:
Patients with thyroid cancer treated with iodine 131 will receive an iodine 131 activity
of between 1100 and 3700 MBq delivered as a capsule orally to eliminate the remaining
thyroid tissue. Hormone replacement therapy (HRT) is then started to correct the
hypothyroidism.
3 days later, a 2D whole body recording will be associated with complementary Single
Photonic Emission Computed Tomography CT scans (SPECT/CT). It enables visualising the
fixation of iodine 131, provides information on the thyroid remnants left in place during
surgical thyroidectomy and to carry out an extension assessment by visualizing the
possible presence of metastases fixing iodine at the level of the regional lymph nodes or
many distant sites, in particular, lung and bone.
In VERICATH study, the hypothesis is that this classic procedure could be advantageously
replaced by a single full-body SPECT/CT recording of a limited duration (≤ 30 minutes),
obtained with a camera state-of-the-art semiconductor device called the VERITON-CT™
(Spectrum Dynamics Medical) camera.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients over the age of 18, who have understood and signed the informed consent
form.
2. Person suffering from thyroid cancer and for whom the multidisciplinary meeting has
validated a treatment by iodine 131 (1100 MBq or 3700 MBq).
3. Person with no contraindication to carrying out the examination.
4. Person affiliated to a social security scheme.
Exclusion Criteria:
1. Person with a known allergy to one of the components of the radiopharmaceutical
(Iodine 131 capsule).
2. Pregnant woman or woman of childbearing age and without suitable contraceptive
means, or breastfeeding mother.
3. Person whose medical condition is unstable and/or unable to remain still in the
supine position during recordings.
4. Person deprived of liberty by a judicial or administrative decision.
5. Person of full age subject to a measure of legal protection (guardianship, curators,
safeguard of justice).
6. Adult person unable to express his consent and who is not the subject of a legal
protection measure.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chru Nancy Brabois
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Start date:
December 26, 2022
Completion date:
April 26, 2025
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05713123
