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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Device
• Intervention / Treatment: Other: A SPECT-CT whole body is added in VERITON-CT camera

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.

• Study Type: Interventional
• Enrollment (Estimated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VERONIQUE ROCH, MSc; Phone Number: +33 0383154276; Email: v.roch@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • Chru Nancy Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq); 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	Other: A SPECT-CT whole body is added in VERITON-CT camera; A SPECT-CT whole body in VERITON-CT camera is added after the conventional procedure recorded in Anger camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare post-therapy imaging performed with the two procedures	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the two procedures in terms of cancer status result.	Status of cancer	18 months
Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera	Measurement of absolute quantification with the 2 procedures	18 months
Evaluate the two exams in terms of ergonomics for technologists	Likert scale results	18 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Elodie CHEVALIER, MD, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2022
• Primary Completion (Estimated): March 26, 2024
• Study Completion (Estimated): October 26, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Thyroid cancer; Iodine 131; Camera CZT (cadmium-Zinc-Tellurid)
• Other Study ID Numbers: 2021PI234

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No