Clinical trial · Interventional
Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy
Contribution of 99mTc-HDP Whole-body SPECT/CT Imaging by VERITON-CT CZT Camera in Stereotactic Radiotherapy Treatment of Bone Metastases of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| whole body SPECT/CT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- whole body SPEC/CT
- description
- Patient will endergo whole body SPECT/CT in treatment position
- interventionNames
- Other: whole body SPECT/CT
Primary outcomes (1)
- measure
- Equivalency of the two treatment plans in quantitative terms
- timeFrame
- 3 years
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
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