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Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy

ConditionProstatic Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCentre Henri Becquerel

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.),

Trial design

Design model

Single group

Treatments tested in this trial

  • whole body SPECT/CT

    Other intervention

    Patient will unergo a whole body SPECT/CT in treatment position

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: whole body SPEC/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years

Secondary outcomes

1

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.

Time frame
3 years
2

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.

Time frame
day of SPECT/CT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Henri Becquerel

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: