Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439784
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-28
Brief Title:
Contribution of the VERITON-CT Camera in Prostate Bone Radiostereotaxy
Sponsor:
Centre Henri Becquerel
Organization:
Centre Henri Becquerel
Study Overview
Official Title:
Contribution of 99mTc-HDP Whole-body SPECTCT Imaging by VERITON-CT CZT Camera in Stereotactic Radiotherapy Treatment of Bone Metastases of Prostate Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VERIOS
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 T126h 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 SPECTCT 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 patients 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 SPECTCT scan of the bone in the treatment position Three hours after injection of 9 MBqkg of 99mTc-HDP CT imaging followed by whole-body SPECTCT 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 SPECTCT data using the segmentation tools available in the Syngovia 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 SPECTCT 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 SPECTCT imaging will then be performed at 3 and 6 months on the conventional examination bed The targets identified during the reference whole-body SPECTCT will be reused in order to measure the evolution of the SUV quantification
Patients will benefit from routine examinations CT scan MRI including a SPECTCT scan of the bone in the treatment position Three hours after injection of 9 MBqkg of 99mTc-HDP CT imaging followed by whole-body SPECTCT 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 SPECTCT data using the segmentation tools available in the Syngovia 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 SPECTCT 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 SPECTCT imaging will then be performed at 3 and 6 months on the conventional examination bed The targets identified during the reference whole-body SPECTCT will be reused in order to measure the evolution of the SUV quantification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None