DeviceVERICATHNCT05713123
Comparison of Record in VERITON Camera to the Anger Camera Procedure in Patients Treated by 131-iodine
A study testing A SPECT-CT whole body is added in VERITON-CT camera in people with Device, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device
- What is being tested?
- A SPECT-CT whole body is added in VERITON-CT camera
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 26 Dec 2022to 26 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chru Nancy Brabois
Vandœuvre-lès-Nancy, 54511
About this study
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
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.
Read the 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.
- Conditions
- Device
- Being tested
- A SPECT-CT whole body is added in VERITON-CT camera
- Keywords
- Iodine 131, Thyroid cancer, Camera CZT (cadmium-Zinc-Tellurid)
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A SPECT-CT whole body is added in VERITON-CT cameraOther
A SPECT-CT whole body in VERITON-CT camera is added after the conventional procedure recorded in Anger camera
| Study group | Role | What they receive |
|---|---|---|
| Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq) | Experimental | 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 Receives: Other: A SPECT-CT whole body is added in VERITON-CT camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
Compare the two procedures in terms of cancer status result.
Status of cancer
Measured: 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
Measured: 18 months
Evaluate the two exams in terms of ergonomics for technologists
Likert scale results
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start26 Dec 2022
- Primary completion26 Dec 2024 (estimated)
- Study completion26 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeviceStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients received Iode 131 for thyroid cancer and 72 hours after taking iodine capsule,
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elodie CHEVALIER, Central Hospital, Nancy, France
- Investigators
- Elodie CHEVALIER, MD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713123
- Sponsor's protocol ID
- 2021PI234
- Acronym
- VERICATH
- Status last verified
- Jun 2024
- First submitted
- 6 Dec 2022
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05713123
- Acronym / sponsor ID
- VERICATH / 2021PI234
- Conditions
- Device
- Keywords
- Iodine 131, Thyroid cancer, Camera CZT (cadmium-Zinc-Tellurid)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 26 Apr 2025 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients received Iode 131 for thyroid cancer and 72 hours after taking iodine capsule,
| Arm | Type | Receives |
|---|---|---|
| Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq) | Experimental | Other: A SPECT-CT whole body is added in VERITON-CT cameraThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A SPECT-CT whole body is added in VERITON-CT cameraA SPECT-CT whole body in VERITON-CT camera is added after the conventional procedure recorded in Anger camera | Other | Person suffering from thyroid cancer and treated by iodine 131 (1100 MBq or 3700 MBq) |
Primary outcome
Compare post-therapy imaging performed with the two procedures
Time frame: 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.
3 secondary outcomes
Compare the two procedures in terms of cancer status result.
Time frame: 18 months
Determine the feasibility of a 3D quantification of the fixation of thyroid residues in a VERITON-CT™ camera
Time frame: 18 months
Evaluate the two exams in terms of ergonomics for technologists
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elodie CHEVALIER, MD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A SPECT-CT whole body is added in VERITON-CT camera in people with Device, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Véronique ROCH, MSc (0383154276 ext. +33, v.roch@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare post-therapy imaging performed with the two procedures (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.