Prostatic CancerVERIOSNCT06439784
Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy
A study testing whole body SPECT/CT in people with Prostatic Cancer, run by Centre Henri Becquerel at 1 site in France.
Trial summary
Stereotactic radiotherapy enables bone metastases to be treated with highly precise irradiation beams, enabling small targets to be irradiated. Planning requires the use of cross-sectional imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Cancer
- What is being tested?
- whole body SPECT/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2026to 15 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years,
- Good general health WHO ≤ 1
- Informed and signed consent prior to any specific study procedure.
- Patient affiliated to the social security system
- Bone metastases from prostate cancer
- Indication for bone stereotactic radiotherapy
Who cannot join
- Presence of active cancer in the previous three years
- Protected adults (under guardianship or curatorship)
- Unable to undergo medical monitoring for geographical, social or psychological reasons
- Unable to decubitus (orthopnea, etc.),
- Hypersensitivity to HDP or to one of the excipients of the radiopharmaceutical.
- History of radiotherapy of the volume to be treated by stereotaxy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Henri Becquerel
Rouen, 76038
Arnaud Dieudonne, PhD, +33232082254, arnaud.dieudonne@chb.unicancer.fr
About this study
Official title: Contribution of 99mTc-HDP Whole-body SPECT/CT Imaging by VERITON-CT CZT Camera in Stereotactic Radiotherapy Treatment of Bone Metastases of Prostate Cancer
Stereotactic radiotherapy enables bone metastases to be treated with highly precise irradiation beams, enabling small targets to be irradiated. Planning requires the use of cross-sectional imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). Bone scintigraphy with Tc99m-labelled biphosphonates (T1/2=6h) is indicated in the extension assessment of prostate cancers. Thanks to the advent of single-photon emission computed tomography (SPECT) based on CZT detectors; whole-body SPECT is now compatible with clinical constraints. We propose to study the value of using whole-body SPECT for planning stereotactic radiotherapy of metastatic prostate cancer. This is a prospective, single-center, non-randomized study involving 30 patients. Patients will benefit from routine examinations (CT scan, MRI) including a bone SPECT/CT in treatment position performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). Planning based on whole-body SPECT images will be carried out remotely from the patient's point of care. The examination will be interpreted by the nuclear physician, and planning will be based on the dosimetric CT scanner, as in standard management. Virtual replanning will be carried out at distance from treatment, incorporating SPECT imaging. Treatment plans with and without SPECT will be compared quantitatively and qualitatively. The feasibility of SPECT imaging in the treatment position will be assessed, enabling lesion location imaging and dosimetric scanning to be performed in a single examination. All therapeutic management and clinical follow-up will be carried out as part of routine care.
Read the detailed description
This is a prospective, single-center, non-randomized study. After a decision in a multidisciplinary consultation meeting, the patient will be offered to join the study. All therapeutic care and clinical follow-up is carried out as part of routine care.
Patients will benefit from routine examinations (CT scan, MRI) including a SPECT/CT scan of the bone in the treatment position. Three hours after injection of 9 MBq/kg of 99mTc-HDP, CT imaging followed by whole-body SPECT/CT will be performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). In order to make the images in the treatment position, the molding of the BodyFIX (Elekta) compression system that is used to reposition the patient between sessions will be made on the examination bed of the VERITON. It is a mattress that stiffens due to air vacuums. It will be placed on an external radiotherapy tray as for the dosimetry scanner. If it is not possible to take the images under these conditions, the patient will benefit from an examination in the standard position.
The images will then be interpreted by a nuclear physician who will identify the targets and define the contours from the SPECT/CT data using the segmentation tools available in the Syngo.via visualization software (Siemens Healthineers, Erlangen, Germany). The images and contours will be anonymized in order to allow blind virtual replanning, at least 6 months before the planning. Non-anonymized images alone will be transmitted as a standard examination, but cannot be incorporated into the treatment plan, as is currently the case.
The patient will benefit from a standard dosimetry scanner for treatment planning. The molding of the mattress made during the SPECT/CT scan of the bone will be reused for the dosimetric scanner. The therapeutic procedure will then follow the local protocol and in line with national recommendations. Whole-body SPECT/CT imaging will then be performed at 3 and 6 months on the conventional examination bed. The targets identified during the reference whole-body SPECT/CT will be reused in order to measure the evolution of the SUV quantification.
- Conditions
- Prostatic Cancer
- Being tested
- whole body SPECT/CT
- Keywords
- whole body SPECT/CT, bone scintigraphy, stereotaxic bone radiation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body SPECT/CTOther
Patient will unergo a whole body SPECT/CT in treatment position
| Study group | Role | What they receive |
|---|---|---|
| whole body SPEC/CT | Experimental | Patient will endergo whole body SPECT/CT in treatment position Receives: Other: whole body SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalency of the two treatment plans in quantitative terms
Let m1 be the mean of a dosimetric index from whole-body 99mTc-HDP-SPECT/CT imaging and m2 the mean of the same dosimetric index from standard imaging, the null hypothesis will be "H0: m1 ≠ m2" and the alternative hypothesis "H1: m1 = m2". Thus, if we reject the null hypothesis at the risk of 5% then we will highlight the equivalence between m1 and m2. The statistical approach to set up such tests is called TOST and will require the definition of appropriate and relevant equivalence limits.
Measured: 3 years
Secondary outcomes (2)
Equivalency of the two treatment plans in qualitative terms
The consortium of radiation therapists will decide which treatment plan will be most beneficial for the patient. The proportion of patients whose SPECT/CT-based plan was chosen will be an indicator of the qualitative impact that this imaging can have on the treatment plan. This proportion will also be associated with its 95% confidence interval for accuracy.
Measured: 3 years
Feasibility of SPECT/CT imaging in treatment position
The number of patients who have been able to benefit from 99mTc-HDP-SPECT/CT imaging in a treatment position usable in dosimetric planning will be the main indicator of feasibility. Depending on the results of the feasibility of this imaging in the treatment position, we can deduce different conclusions: If the feasibility is demonstrated (25/30 patients) and the primary outcome does not show a difference between the two treatment plans, we will conclude that 99mTc-HDP-SPECT/CT imaging in the treatment position can be substituted for the standard simulation CT scanner. If feasibility is not demonstrated and the primary outcome does not show a difference between the two treatment plans, we will conclude that 99mTc-HDP-SPECT /CT imaging in the treatment position does not contribute to dosimetry planning.
Measured: day of SPECT/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dieudonne, PhD, Study director, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439784
- Sponsor's protocol ID
- CHB23.06
- Acronym
- VERIOS
- Status last verified
- Jul 2026
- First submitted
- 28 May 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of 99mTc-HDP Whole-body SPECT/CT Imaging by VERITON-CT CZT Camera in Stereotactic Radiotherapy Treatment of Bone Metastases of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06439784
- Acronym / sponsor ID
- VERIOS / CHB23.06
- Conditions
- Prostatic Cancer
- Keywords
- whole body SPECT/CT, bone scintigraphy, stereotaxic bone radiation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 3 Jun 2024 (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.
Stereotactic radiotherapy enables bone metastases to be treated with highly precise irradiation beams, enabling small targets to be irradiated. Planning requires the use of cross-sectional imaging such as computed tomography (CT) or magnetic resonance imaging (MRI). Bone scintigraphy with Tc99m-labelled biphosphonates (T1/2=6h) is indicated in the extension assessment of prostate cancers. Thanks to the advent of single-photon emission computed tomography (SPECT) based on CZT detectors; whole-body SPECT is now compatible with clinical constraints. We propose to study the value of using whole-body SPECT for planning stereotactic radiotherapy of metastatic prostate cancer. This is a prospective, single-center, non-randomized study involving 30 patients. Patients will benefit from routine examinations (CT scan, MRI) including a bone SPECT/CT in treatment position performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). Planning based on whole-body SPECT images will be carried out remotely from the patient's point of care. The examination will be interpreted by the nuclear physician, and planning will be based on the dosimetric CT scanner, as in standard management. Virtual replanning will be carried out at distance from treatment, incorporating SPECT imaging. Treatment plans with and without SPECT will be compared quantitatively and qualitatively. The feasibility of SPECT imaging in the treatment position will be assessed, enabling lesion location imaging and dosimetric scanning to be performed in a single examination. All therapeutic management and clinical follow-up will be carried out as part of routine care.
Detailed description
This is a prospective, single-center, non-randomized study. After a decision in a multidisciplinary consultation meeting, the patient will be offered to join the study. All therapeutic care and clinical follow-up is carried out as part of routine care.
Patients will benefit from routine examinations (CT scan, MRI) including a SPECT/CT scan of the bone in the treatment position. Three hours after injection of 9 MBq/kg of 99mTc-HDP, CT imaging followed by whole-body SPECT/CT will be performed on the VERITON-CT (Spectrum Dynamics, Haifa, Israel). In order to make the images in the treatment position, the molding of the BodyFIX (Elekta) compression system that is used to reposition the patient between sessions will be made on the examination bed of the VERITON. It is a mattress that stiffens due to air vacuums. It will be placed on an external radiotherapy tray as for the dosimetry scanner. If it is not possible to take the images under these conditions, the patient will benefit from an examination in the standard position.
The images will then be interpreted by a nuclear physician who will identify the targets and define the contours from the SPECT/CT data using the segmentation tools available in the Syngo.via visualization software (Siemens Healthineers, Erlangen, Germany). The images and contours will be anonymized in order to allow blind virtual replanning, at least 6 months before the planning. Non-anonymized images alone will be transmitted as a standard examination, but cannot be incorporated into the treatment plan, as is currently the case.
The patient will benefit from a standard dosimetry scanner for treatment planning. The molding of the mattress made during the SPECT/CT scan of the bone will be reused for the dosimetric scanner. The therapeutic procedure will then follow the local protocol and in line with national recommendations. Whole-body SPECT/CT imaging will then be performed at 3 and 6 months on the conventional examination bed. The targets identified during the reference whole-body SPECT/CT will be reused in order to measure the evolution of the SUV quantification.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| whole body SPEC/CT | Experimental | Other: whole body SPECT/CTPatient will endergo whole body SPECT/CT in treatment position |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years,
- Good general health WHO ≤ 1
- Informed and signed consent prior to any specific study procedure.
- Patient affiliated to the social security system
- Bone metastases from prostate cancer
Key exclusion criteria (6 listed)
- Presence of active cancer in the previous three years
- Protected adults (under guardianship or curatorship)
- Unable to undergo medical monitoring for geographical, social or psychological reasons
- Unable to decubitus (orthopnea, etc.),
- Hypersensitivity to HDP or to one of the excipients of the radiopharmaceutical.
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 |
|---|---|---|
| whole body SPECT/CTPatient will unergo a whole body SPECT/CT in treatment position | Other | whole body SPEC/CT |
Primary outcome
Equivalency of the two treatment plans in quantitative terms
Time frame: 3 years
Let m1 be the mean of a dosimetric index from whole-body 99mTc-HDP-SPECT/CT imaging and m2 the mean of the same dosimetric index from standard imaging, the null hypothesis will be "H0: m1 ≠ m2" and the alternative hypothesis "H1: m1 = m2". Thus, if we reject the null hypothesis at the risk of 5% then we will highlight the equivalence between m1 and m2. The statistical approach to set up such tests is called TOST and will require the definition of appropriate and relevant equivalence limits.
2 secondary outcomes
Equivalency of the two treatment plans in qualitative terms
Time frame: 3 years
Feasibility of SPECT/CT imaging in treatment position
Time frame: day of SPECT/CT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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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.
Arnaud Dieudonne, PhD study director
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body SPECT/CT in people with Prostatic Cancer, run by Centre Henri Becquerel 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 6 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: opening soon, as of the sponsor's last update on 24 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Dieudonne, PhD (+33232082254, arnaud.dieudonne@chb-unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalency of the two treatment plans in quantitative terms (time frame: 3 years). 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 24 Jul 2026.