Clinical trial NCT05713123: Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine
Official title: Comparison of a 3D Recording in a VERITON-CT™ Camera to the Anger Camera Procedure in Patients Treated by Iodine 131 for a Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Device
Keywords: Iodine 131
Thyroid cancer
Camera CZT (cadmium-Zinc-Tellurid)
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients received Iode 131 for thyroid cancer and 72 hours after taking iodine capsule,
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Compare post-therapy imaging performed with the two procedures
timeFrame: 18 months
Secondary outcomes:
measure: Compare the two procedures in terms of cancer status result.
timeFrame: 18 months
measure: Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera
timeFrame: 18 months
measure: Evaluate the two exams in terms of ergonomics for technologists
timeFrame: 18 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy Brabois
Study officials:
affiliation: CHRU Nancy
name: Elodie CHEVALIER, MD
role: PRINCIPAL_INVESTIGATOR
References: