Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine
- Conditions
- Device
- Registration Number
- NCT05713123
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 77
- Patients over the age of 18, who have understood and signed the informed consent form.
- Person suffering from thyroid cancer and for whom the multidisciplinary meeting has validated a treatment by iodine 131 (1100 MBq or 3700 MBq).
- Person with no contraindication to carrying out the examination.
- Person affiliated to a social security scheme.
- Person with a known allergy to one of the components of the radiopharmaceutical (Iodine 131 capsule).
- Pregnant woman or woman of childbearing age and without suitable contraceptive means, or breastfeeding mother.
- Person whose medical condition is unstable and/or unable to remain still in the supine position during recordings.
- Person deprived of liberty by a judicial or administrative decision.
- Person of full age subject to a measure of legal protection (guardianship, curators, safeguard of justice).
- Adult person unable to express his consent and who is not the subject of a legal protection measure.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Compare post-therapy imaging performed with the two procedures 18 months Type of lesions
* Lesions
* The nature of the lesion(s): thyroid residue and/or lymph node lesion and/or metastases (distant lesions).
* Number of lesions in conventional camera and in VERITON-CT™ camera.
- Secondary Outcome Measures
Name Time Method Compare the two procedures in terms of cancer status result. 18 months Status of cancer
Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera 18 months Measurement of absolute quantification with the 2 procedures
Evaluate the two exams in terms of ergonomics for technologists 18 months Likert scale results
Trial Locations
- Locations (1)
Chru Nancy Brabois
🇫🇷Vandœuvre-lès-Nancy, France
Chru Nancy Brabois🇫🇷Vandœuvre-lès-Nancy, France