Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine (VERICATH)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Device

Treatments: Other: A SPECT-CT whole body is added in VERITON-CT camera

Study type: Interventional

Funder types: Other

Identifiers

NCT05713123

2021PI234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq)

Experimental group

Description:

The study will be offered to patients suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq). When they come in nuclear medicine to have the iodine scan in Anger's camera, if they signed the consent, they will the SPECT/CT whole body in VERITON-CT camera

Treatment:

Other: A SPECT-CT whole body is added in VERITON-CT camera