Radiation ExposureNCT03649451
Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms
An observational study of Radiation Exposure, run by Societe Francaise de Physique Medicale at 1 site in France.
Trial summary
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize… Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Radiation Exposure
- How many people
- 8,840 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2018to 30 Aug 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population consists on unhealthy patients undergoing surgical procedures with the use of X-ray mobile equipement. 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic, digestive, urology, cardiology, vascular and multi-specialty) are included in this study. For each procedure and each participating institution among the 73 centers that have sent their participation agreement, 15 to 30 procedures will be collected and analysed.
Who may be able to join
- Fluoroscopy guided procedures performed on adult patients (≥16 years old)
- Fluoroscopy guided procedures performed with mobile X-ray systems. Procedures performed outside of the operating rooms but using mobile X-ray systems are included in this study.
- Fluoroscopy guided procedures performed using mini C-arms or O-arms
Who cannot join
- Fluoroscopy guided procedures performed on pediatric patients (<16 years old)
- Fluoroscopy guided procedures performed with a fixed interventional radiology imaging system even if it was located in the operating rooms .
- Medical procedures performed using both a mobile X-ray system and a fixed CT scanner.
- Medical procedures performed using a mobile intra-operative CT scanner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection.
This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care.
Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.
Read the detailed description
Context:
Reference dose levels, introduced by the International Commission on Radiological Protection (ICRP) in 1996, are intended to help professionals using medical imaging to evaluate their practice and optimize patient's doses. European directive 2013/59/Euratom emphasizes the need to establish, use and regularly review reference levels for diagnostic and interventional procedures and to publish guidelines on this topic. Furthermore, national reference levels were established for conventional radiology and CT exams. They are used as a tool for the optimization of medical practices. Besides, a working group of the French Society of Medical Physics (SFPM) has published in 2017 reference levels for interventional radiology procedures performed in a dedicated room and using fixed angiographic equipment. Although radiation protection is a big challenge encountered in operating rooms using mobile X-ray equipment, few data are available in the literature regarding the use of this type of equipment.
In this context, the SFPM suggested the creation of a working group in 2017 to establish reference levels for the main procedures realized in the operating rooms using mobile X-ray systems. The aim of this working group is to help medical physicists and surgeons in evaluating their practice and optimizing patient radiation protection.
Scope of the study: The main purpose of the study is to establish dosimetric reference levels, in terms of KAP (Kerma-Area-Product). Additional objectives consist on proposing reference levels in terms of fluoroscopy time and air kerma and on studying the impact of different parameters (surgical specialty, body mass index, use of zoom, fluoroscopy pulse rate) on the delivered doses.
Study type and cohort: This is a multi-centric prospective study which consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 surgical procedures (n=62) belonging to 7 different surgery specialties. Selected specialties are neurosurgery (n=12), orthopedic surgery (n=15), digestive surgery (n=6), urology (n=10), cardiology (n=6), vascular surgery (n=11), multi-specialty (n=2). 73 health institutions of different categories (University hospitals, clinics, centers dedicated to cancer treatment, etc..) confirmed their participations to the study.
Data collection: Data will be collected using a password-protected Excel spreadsheet. This excel file will be sent to all the participating institutions at the beginning of data collection. Every institution will send the excel file completed with anonymized data to the scientific responsible of the study through the secure email server of the APHP (Assistance Publique des Hopitaux de Paris)) institution.
Analysis: The main goal of this study is to publish descriptive statistics parameters (mean, standard deviation, median, 1st quartile, 3rd quartile) for each dosimetric data (KAP, fluoroscopy time, kerma, etc..) and for each category of surgical procedures. Results will be presented with a 95 percentage confidence interval.
Moreover, correlation analysis between several variables will be done. The differences between detector and equipment technologies will be also studied using appropriate statistical tests.
- Conditions
- Radiation Exposure
- Keywords
- Reference dose levels, Surgery, C-arm, Orthopedic, Urology, Vascular, Neurosurgery, Cardiology, Digestive, Fluoroscopy, Patient radiation protection, X-ray, Interventional radiology, Optimization, Kerma Area Product
What is being measured
The primary outcome is the main question the study is designed to answer.
Total KAP (Kerma-Air-Product)
KAP or Kerma-Area-Product is the main dosimetric parameter representing the patient exposure. Participants should choose the appropriate unit of the KAP among a list of five units (microGray.m², milliGray.centimeter², centiGray.centimeter², deciGray.centimeter², Gray.centimeter²). Note that Gray is the international unit of the radiation quantity.
Measured: KAP is provided by the X-ray equipment at the end of the procedure.
Secondary outcomes (19)
Year of construction of the equipment and date of the last external quality control (QC) (yyyy)
Year of construction of the equipment and date of the last external quality control
Measured: baseline
Image receptor type of the equipment
Participants should specify whether the images are obtained using a flat panel detector or an X-ray image intensifier.
Measured: baseline
DACS Connection
Participants should specify If the X-ray equipment is connected to a Dose Archiving and a Communication system (DACS) (Yes/no)
Measured: baseline
Patient weight (kg) and height (cm)
Weight and height will be combined to report BMI in kg/m^2.
Measured: Patient weight and height are provided from the equipment or given by the medical team during the procedure
Size of Fields of View (FOV) (cm)
Size of the smallest and largest Field of View (FOV); size of the largest FOV adapted to the size of the phantom; size of the most used FOV for the concerned procedure. (cm)
Measured: Baseline, The most used FOV during the procedure is provided by the medical staff
Differences between the displayed and measured X-ray doses (percentage)
Differences between the displayed and measured KAP for the smallest and biggest FOV; Differences between the displayed and measured air kerma available in the last quality control (QC) report. (Percentages).
Measured: baseline
Total air kerma of the procedure including the one performed of an O-arm equipment
Participants should specify the unit by choosing the appropriate one among a list of 5 units (micro Gray, milli Gray, centi Gray, deci Gray, Gray).
Measured: Data are provided by the X-ray equipment at the end of the procedure
Total number of image frames (number)
Total number of image frames (number)
Measured: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy mode used during the procedure
Participants should specify whether continuous, pulsed or mixed fluoroscopy modes are used during the procedure
Measured: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy pulse rate ( pulses/second)
Measured: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy time (hh:mm:ss) of the procedure including the one performed of an O-arm equipment
Measured: Data are provided by the X-ray equipment at the end of the procedure
KAP (Kerma-Area-Product) attributable to fluoroscopy
Participants should choose the appropriate unit of the KAP among a list of five units (µGy.m², mGy.cm², cGy.cm², dGy.cm², Gy.cm²).
Measured: Data are provided by the X-ray equipment at the end of the procedure
Medical specialty of the procedure
Participants should specify the medical specialty of the procedure by selecting one from a predefined list of seven categories: Orthopedic surgery, neurosurgery, cardiology, vascular surgery, urology, digestive surgery and multi-specialty.
Measured: Data are provided by the medical staff during the procedure
Name/type of the procedure
Participants should specify the medical description of the procedure.
Measured: Data are provided by the medical staff during the procedure
Additional information about the procedure giving further indications about the used materials or the anatomical region of interest.
Measured: Data are provided by the medical staff during the procedure
Total KAP for procedures performed on an O-arm equipment
Participants should choose the appropriate unit of the KAP among a list of five units (µGy.m², mGy.cm², cGy.cm², dGy.cm², Gy.cm²).
Measured: KAP is provided by the X-ray equipment at the end of the procedure
Total DLP (Dose-Length-Product) of the procedures performed on an O-arm equipment.DLP is always expressed in mGy.cm.
The DLP (Dose Length Product) is expressed in milliGray *centimeters (mGy.cm)
Measured: DLP is provided by the X-ray equipment at the end of the procedure
CTDIvol (Volume Computed Tomography Dose Index) of the procedures performed on an O-arm equipment. CTDI is always expressed in mGy.
The CTDIvol is a standardized measure of radiation dose output of a CT scanner. This dose is expressed in milliGrays (mGy).
Measured: CTDIvol is provided by the X-ray equipment at the end of the procedure
Type of the dosimetric phantom used to calculate the CTDI of an acquisition for the procedures performed on an O-arm equipment.
Participants should select between a "head phantom (16 cm)" or a "body phantom (32 cm)"
Measured: Data are provided by the X-ray equipment at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start3 Sep 2018
- Primary completion30 Mar 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 8,840 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Societe Francaise de Physique Medicale
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Lariboisière, University Hospital, Angers, University hospital of Montpellier, FRANCE, Fréjus-Saint-Raphaël hospital, FRANCE, C2i Santé, FRANCE
- Responsible party
- Sponsor
- Investigators
- Djamel DABLI, PhD, Principal investigator, University hospital of Nîmes, FranceBrice ROYER, MS, Principal investigator, C2i Santé, FRANCEMathilde DEMONCHY, PhD, Principal investigator, Fréjus-Saint-Raphaël hospital, FRANCEJulien LE ROY, PhD, Principal investigator, University hospital of Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649451
- Sponsor's protocol ID
- gtsfpmnrbloc2017
- Status last verified
- May 2020
- First submitted
- 2 Aug 2018
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the final results of this study will be shared with the medical physicist members of the French Society of Medical Physicist. These results are statistical data analysis based on the collected patient data. Moreover, the study main results would be probably shared with the scientific community through a published paper in a scientific peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms
- ClinicalTrials.gov ID
- NCT03649451
- Acronym / sponsor ID
- gtsfpmnrbloc2017
- Conditions
- Radiation Exposure
- Keywords
- Reference dose levels, Surgery, C-arm, Orthopedic, Urology, Vascular, Neurosurgery, Cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,840 participants (actual)
- Lead sponsor
- Societe Francaise de Physique MedicaleUniversity, hospital or other
- Collaborators
- Hopital Lariboisière, University Hospital, Angers, University hospital of Montpellier, FRANCE, Fréjus-Saint-Raphaël hospital, FRANCE, C2i Santé, FRANCE
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 28 Aug 2018 (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.
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection.
This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care.
Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.
Detailed description
Context:
Reference dose levels, introduced by the International Commission on Radiological Protection (ICRP) in 1996, are intended to help professionals using medical imaging to evaluate their practice and optimize patient's doses. European directive 2013/59/Euratom emphasizes the need to establish, use and regularly review reference levels for diagnostic and interventional procedures and to publish guidelines on this topic. Furthermore, national reference levels were established for conventional radiology and CT exams. They are used as a tool for the optimization of medical practices. Besides, a working group of the French Society of Medical Physics (SFPM) has published in 2017 reference levels for interventional radiology procedures performed in a dedicated room and using fixed angiographic equipment. Although radiation protection is a big challenge encountered in operating rooms using mobile X-ray equipment, few data are available in the literature regarding the use of this type of equipment.
In this context, the SFPM suggested the creation of a working group in 2017 to establish reference levels for the main procedures realized in the operating rooms using mobile X-ray systems. The aim of this working group is to help medical physicists and surgeons in evaluating their practice and optimizing patient radiation protection.
Scope of the study: The main purpose of the study is to establish dosimetric reference levels, in terms of KAP (Kerma-Area-Product). Additional objectives consist on proposing reference levels in terms of fluoroscopy time and air kerma and on studying the impact of different parameters (surgical specialty, body mass index, use of zoom, fluoroscopy pulse rate) on the delivered doses.
Study type and cohort: This is a multi-centric prospective study which consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 surgical procedures (n=62) belonging to 7 different surgery specialties. Selected specialties are neurosurgery (n=12), orthopedic surgery (n=15), digestive surgery (n=6), urology (n=10), cardiology (n=6), vascular surgery (n=11), multi-specialty (n=2). 73 health institutions of different categories (University hospitals, clinics, centers dedicated to cancer treatment, etc..) confirmed their participations to the study.
Data collection: Data will be collected using a password-protected Excel spreadsheet. This excel file will be sent to all the participating institutions at the beginning of data collection. Every institution will send the excel file completed with anonymized data to the scientific responsible of the study through the secure email server of the APHP (Assistance Publique des Hopitaux de Paris)) institution.
Analysis: The main goal of this study is to publish descriptive statistics parameters (mean, standard deviation, median, 1st quartile, 3rd quartile) for each dosimetric data (KAP, fluoroscopy time, kerma, etc..) and for each category of surgical procedures. Results will be presented with a 95 percentage confidence interval.
Moreover, correlation analysis between several variables will be done. The differences between detector and equipment technologies will be also studied using appropriate statistical tests.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population consists on unhealthy patients undergoing surgical procedures with the use of X-ray mobile equipement. 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic, digestive, urology, cardiology, vascular and multi-specialty) are included in this study. For each procedure and each participating institution among the 73 centers that have sent their participation agreement, 15 to 30 procedures will be collected and analysed.
Key inclusion criteria (3 listed)
- Fluoroscopy guided procedures performed on adult patients (≥16 years old)
- Fluoroscopy guided procedures performed with mobile X-ray systems. Procedures performed outside of the operating rooms but using mobile X-ray systems are included in this study.
- Fluoroscopy guided procedures performed using mini C-arms or O-arms
Key exclusion criteria (4 listed)
- Fluoroscopy guided procedures performed on pediatric patients (<16 years old)
- Fluoroscopy guided procedures performed with a fixed interventional radiology imaging system even if it was located in the operating rooms .
- Medical procedures performed using both a mobile X-ray system and a fixed CT scanner.
- Medical procedures performed using a mobile intra-operative CT scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total KAP (Kerma-Air-Product)
Time frame: KAP is provided by the X-ray equipment at the end of the procedure.
KAP or Kerma-Area-Product is the main dosimetric parameter representing the patient exposure. Participants should choose the appropriate unit of the KAP among a list of five units (microGray.m², milliGray.centimeter², centiGray.centimeter², deciGray.centimeter², Gray.centimeter²). Note that Gray is the international unit of the radiation quantity.
19 secondary outcomes
Year of construction of the equipment and date of the last external quality control (QC) (yyyy)
Time frame: baseline
Image receptor type of the equipment
Time frame: baseline
DACS Connection
Time frame: baseline
Patient weight (kg) and height (cm)
Time frame: Patient weight and height are provided from the equipment or given by the medical team during the procedure
Size of Fields of View (FOV) (cm)
Time frame: Baseline, The most used FOV during the procedure is provided by the medical staff
Differences between the displayed and measured X-ray doses (percentage)
Time frame: baseline
Total air kerma of the procedure including the one performed of an O-arm equipment
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Total number of image frames (number)
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy mode used during the procedure
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy pulse rate ( pulses/second)
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Fluoroscopy time (hh:mm:ss) of the procedure including the one performed of an O-arm equipment
Time frame: Data are provided by the X-ray equipment at the end of the procedure
KAP (Kerma-Area-Product) attributable to fluoroscopy
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Medical specialty of the procedure
Time frame: Data are provided by the medical staff during the procedure
Name/type of the procedure
Time frame: Data are provided by the medical staff during the procedure
Additional information about the procedure giving further indications about the used materials or the anatomical region of interest.
Time frame: Data are provided by the medical staff during the procedure
Total KAP for procedures performed on an O-arm equipment
Time frame: KAP is provided by the X-ray equipment at the end of the procedure
Total DLP (Dose-Length-Product) of the procedures performed on an O-arm equipment.DLP is always expressed in mGy.cm.
Time frame: DLP is provided by the X-ray equipment at the end of the procedure
CTDIvol (Volume Computed Tomography Dose Index) of the procedures performed on an O-arm equipment. CTDI is always expressed in mGy.
Time frame: CTDIvol is provided by the X-ray equipment at the end of the procedure
Type of the dosimetric phantom used to calculate the CTDI of an acquisition for the procedures performed on an O-arm equipment.
Time frame: Data are provided by the X-ray equipment at the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Individual participant dataSharing planned: No. Only the final results of this study will be shared with the medical physicist members of the French Society of Medical Physicist. These results are statistical data analysis based on the collected patient data. Moreover, the study main results would be probably shared with the scientific community through a published paper in a scientific peer-reviewed journal.
Related trials for Radiation Exposure
RecruitingObservational study
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Operator Radiation Exposure
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
Enrolling by invitation
Personalizing Veterans' Lung Cancer Screening and Diagnosis
Lung Cancer Screening, Military Service-related Environmental and Occupational Exposures
Not yet recruiting
Clinical Evaluation of a Novel Textile Radiation Protection Device
Radiation Exposure
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. This study is not recruiting at the moment.
Djamel DABLI, PhD principal investigator
University hospital of Nîmes, France
Brice ROYER, MS principal investigator
C2i Santé, FRANCE
Mathilde DEMONCHY, PhD principal investigator
Fréjus-Saint-Raphaël hospital, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Exposure, run by Societe Francaise de Physique Medicale 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total KAP (Kerma-Air-Product) (time frame: KAP is provided by the X-ray equipment at the end of the procedure.). 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 13 May 2020; AzTrials last refreshed its copy on 28 Oct 2026.