Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy

NCT06439784 | Not Yet Recruiting

• 1 other identifier: CHB23.06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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

Prostatic Cancer

Keywords

whole body SPECT/CT; bone scintigraphy; stereotaxic bone radiation therapy

Outcome Measures

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.

  3 years

Secondary Outcomes (2)

• Equivalency of the two treatment plans in qualitative terms

  3 years

• Feasibility of SPECT/CT imaging in treatment position

  day of SPECT/CT

Study Arms (1)

whole body SPEC/CT

EXPERIMENTAL

Patient will endergo whole body SPECT/CT in treatment position

Other: whole body SPECT/CT

Interventions

whole body SPECT/CT OTHER

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

whole body SPEC/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Arnaud Dieudonne, PhD

  Centre Henri Becquerel

  STUDY DIRECTOR

Central Study Contacts

Arnaud Dieudonne, PhD

CONTACT

+33232082254; arnaud.dieudonne@chb-unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb-unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: June 15, 2024
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 3, 2024

Record last verified: 2024-05

Locations

FR (1)