Skeletal ScintigraphyREANCT03458585
Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic Scans
An observational study of Skeletal Scintigraphy and FDG PET/CT, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This questionnaire is aimed at finding out if patients understand how much radiation they are being exposed to when they have a bone scan (99mTc-MDP)or an FDG PET/CT scan (18F-FDG PET/CT). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skeletal Scintigraphy, FDG PET/CT
- What is being tested?
- Self-administered questionnaire
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2018to 31 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: patients attending 99mTc-MDP bone scans. Group 2: patients attending 18F- FDG PET/CT scans.
Who may be able to join
- Over the age of 18
- Group 1: undergoing a diagnostic bone scan within the Nuclear Medicine and PET/CT Department at The Royal Marsden Hospital
- Group 2: undergoing a diagnostic 18F- FDG PET/CT within the Nuclear Medicine and PET/CT Department at The Royal Marsden Hospital.
Who cannot join
- Previous participation in one group; (participants can only take part in one of the group questionnaires once).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden Hospital NHS Trust Foundation
Sutton, Surrey, SM2 5PT
About this study
Official title: Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic 99mTc-MDP Bone Scans and 18F-FDG PET/CT Scans
This questionnaire is aimed at finding out if patients understand how much radiation they are being exposed to when they have a bone scan (99mTc-MDP)or an FDG PET/CT scan (18F-FDG PET/CT). This questionnaire is also interested in understanding if patients consider current leaflet information sent with appointment letter as sufficient to understand what the radiation dose from that scan is.
By collecting information on how much patients are aware and understand about radiation exposure, we can use this information to develop better guidance for medical staff who advise patients as well as clearer information leaflets for patients to assist in their understanding.
Read the detailed description
Nuclear medicine uses ionizing radiation in order to diagnose and treat diseases and the different types of scans and therapies use different amounts and types of radiation which result in different exposures. For example in the UK the average natural background radiation levels is around 2.2 mSv and a Chest X-ray is about 0.014 mSv, which is equivalent to approximately 2.5 days of natural background radiation in the UK.
When undergoing clinical nuclear medicine scans such as 99mTC-MDP bone scans and 18F-FDG PET/CT scans, two of the most common procedures within nuclear medicine the current information made available to patients from clinicians and current information leaflets for both procedures may not be detailed enough to enable patients to understand about radiation exposure and make an informed decision to undergo the procedures.
With bone scans accounting for 27% of all conventional nuclear medicine procedures and 18F-FDG PET/CT scans accounting for 78% of total number of PET/CT procedures across the trust and similarly across the majority of nuclear medicine departments in England, this questionnaire aims to capture current knowledge and awareness of patients in terms of radiation exposure when they are referred for a nuclear medicine scan, their views on the current appropriateness of leaflets provided and how would they would prefer to receive that information.
This information will be used to potentially educate the medical staff on the need to correctly inform the patient with regards to radiation exposure; to standardize the information that is given to patients and to potentially design new information leaflets and request forms.
The current trust leaflets across all nuclear medicine procedures involving an injection of radiopharmaceutical have the same explanation under "Is there any risk from the radiation? The amount of radiation involved is small and similar to the amount used in some x-ray procedures." When in actual fact the exposure from a bone scan is around 4 mSv and the exposure from an 18F-FDG PET/CT is around 14 mSv which is significantly differently.
This is a cross sectional questionnaire study aimed at gaining a greater understanding of the patient perception and awareness of radiation exposure when undertaking a nuclear medicine 99mTc-MDP bone scan or 18F- FDG PET/CT scan.
Upon completion, patients will be given the fourth sheet of the cover letter with answers to questions on section 3. If patients have additional questions pertinent to the radiation exposure comparators they will be directed to the section on the cover letter where they can find more information regarding this subject. As appropriate questions will also be directed to the Principal Investigator who is Head of Radiation Protection at current Trust.
- Conditions
- Skeletal Scintigraphy, FDG PET/CT
- Being tested
- Self-administered questionnaire
- Keywords
- ionising radiation, patient awareness, patient knowledge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnaireOther
Self-administered questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group 1: patients attending for a 99mTc-MDP bone scan. | Group 1: Patients will be approached after they had their injection for the bone scan procedure. Completion of questionnaire will take place during the three hour uptake period, before they have the scan. Receives: Other: Self-administered questionnaire | |
| Group 2: patients attending for a 18F- FDG PET/CT scan. | Group 2: Patients will be approached and consented after they had their injection and scan for 18F- FDG PET/CT. Completion of questionnaire will take place immediately after patients have changed and wait to leave the department, while they wait for their scan to be checked . Receives: Other: Self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported knowledge of patients undergoing bone scan or FDG PET/CT
Self-administered questionnaire will be used to collect information on patient knowledge regarding exposure to ionising radiation when having the nuclear medicine scans such as bone scan or FDG PET/CT
Measured: 9 months
Secondary outcomes (2)
Qualitative assessment on current leaflets for bone scans and FDG PET/CT scans
Two open questions will be used to collect patients views and suggestions on information regarding doses of radiation used in the 2 procedures. Thematic analysis will be used to analyse data.
Measured: 9 months
Demographic correlations with self-reported knowledge
Statistical correlations with age, gender, previous scans, level of education, confidence in completing medical forms and self-reported knowledge.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start26 Feb 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal ScintigraphyStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- City, University of London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458585
- Sponsor's protocol ID
- CCR 4835
- Acronym
- REA
- Status last verified
- Mar 2018
- First submitted
- 20 Feb 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Presentations and publications require authorisation by the CI who is responsible for the study. The International Committee of Medical Journal Editors (ICMJE) requires clinical trials to be entered onto a recognised registry before recruitment of the first patient, in order for the trial to be published in an ICMJE journal. This study will be registered on www.clinicaltrials.gov. A summary of the study findings will be available in the trust website.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic 99mTc-MDP Bone Scans and 18F-FDG PET/CT Scans
- ClinicalTrials.gov ID
- NCT03458585
- Acronym / sponsor ID
- REA / CCR 4835
- Conditions
- Skeletal Scintigraphy, FDG PET/CT
- Keywords
- ionising radiation, patient awareness, patient knowledge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- City, University of London
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Mar 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 questionnaire is aimed at finding out if patients understand how much radiation they are being exposed to when they have a bone scan (99mTc-MDP)or an FDG PET/CT scan (18F-FDG PET/CT). This questionnaire is also interested in understanding if patients consider current leaflet information sent with appointment letter as sufficient to understand what the radiation dose from that scan is.
By collecting information on how much patients are aware and understand about radiation exposure, we can use this information to develop better guidance for medical staff who advise patients as well as clearer information leaflets for patients to assist in their understanding.
Detailed description
Nuclear medicine uses ionizing radiation in order to diagnose and treat diseases and the different types of scans and therapies use different amounts and types of radiation which result in different exposures. For example in the UK the average natural background radiation levels is around 2.2 mSv and a Chest X-ray is about 0.014 mSv, which is equivalent to approximately 2.5 days of natural background radiation in the UK.
When undergoing clinical nuclear medicine scans such as 99mTC-MDP bone scans and 18F-FDG PET/CT scans, two of the most common procedures within nuclear medicine the current information made available to patients from clinicians and current information leaflets for both procedures may not be detailed enough to enable patients to understand about radiation exposure and make an informed decision to undergo the procedures.
With bone scans accounting for 27% of all conventional nuclear medicine procedures and 18F-FDG PET/CT scans accounting for 78% of total number of PET/CT procedures across the trust and similarly across the majority of nuclear medicine departments in England, this questionnaire aims to capture current knowledge and awareness of patients in terms of radiation exposure when they are referred for a nuclear medicine scan, their views on the current appropriateness of leaflets provided and how would they would prefer to receive that information.
This information will be used to potentially educate the medical staff on the need to correctly inform the patient with regards to radiation exposure; to standardize the information that is given to patients and to potentially design new information leaflets and request forms.
The current trust leaflets across all nuclear medicine procedures involving an injection of radiopharmaceutical have the same explanation under "Is there any risk from the radiation? The amount of radiation involved is small and similar to the amount used in some x-ray procedures." When in actual fact the exposure from a bone scan is around 4 mSv and the exposure from an 18F-FDG PET/CT is around 14 mSv which is significantly differently.
This is a cross sectional questionnaire study aimed at gaining a greater understanding of the patient perception and awareness of radiation exposure when undertaking a nuclear medicine 99mTc-MDP bone scan or 18F- FDG PET/CT scan.
Upon completion, patients will be given the fourth sheet of the cover letter with answers to questions on section 3. If patients have additional questions pertinent to the radiation exposure comparators they will be directed to the section on the cover letter where they can find more information regarding this subject. As appropriate questions will also be directed to the Principal Investigator who is Head of Radiation Protection at current Trust.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: patients attending for a 99mTc-MDP bone scan. | – | Other: Self-administered questionnaireGroup 1: Patients will be approached after they had their injection for the bone scan procedure. Completion of questionnaire will take place during the three hour uptake period, before they have the scan. |
| Group 2: patients attending for a 18F- FDG PET/CT scan. | – | Other: Self-administered questionnaireGroup 2: Patients will be approached and consented after they had their injection and scan for 18F- FDG PET/CT. Completion of questionnaire will take place immediately after patients have changed and wait to leave the department, while they wait for their scan to be checked . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: patients attending 99mTc-MDP bone scans. Group 2: patients attending 18F- FDG PET/CT scans.
Key inclusion criteria (3 listed)
- Over the age of 18
- Group 1: undergoing a diagnostic bone scan within the Nuclear Medicine and PET/CT Department at The Royal Marsden Hospital
- Group 2: undergoing a diagnostic 18F- FDG PET/CT within the Nuclear Medicine and PET/CT Department at The Royal Marsden Hospital.
Key exclusion criteria (1 listed)
- Previous participation in one group; (participants can only take part in one of the group questionnaires once).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered questionnaireSelf-administered questionnaire | Other | Group 1: patients attending for a 99mTc-MDP bone scan., Group 2: patients attending for a 18F- FDG PET/CT scan. |
Primary outcome
Self-reported knowledge of patients undergoing bone scan or FDG PET/CT
Time frame: 9 months
Self-administered questionnaire will be used to collect information on patient knowledge regarding exposure to ionising radiation when having the nuclear medicine scans such as bone scan or FDG PET/CT
2 secondary outcomes
Qualitative assessment on current leaflets for bone scans and FDG PET/CT scans
Time frame: 9 months
Demographic correlations with self-reported knowledge
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: Undecided. Presentations and publications require authorisation by the CI who is responsible for the study. The International Committee of Medical Journal Editors (ICMJE) requires clinical trials to be entered onto a recognised registry before recruitment of the first patient, in order for the trial to be published in an ICMJE journal. This study will be registered on www.clinicaltrials.gov. A summary of the study findings will be available in the trust website.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Skeletal Scintigraphy and FDG PET/CT, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Jun 2018. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Self-reported knowledge of patients undergoing bone scan or FDG PET/CT (time frame: 9 months). 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 29 Jun 2018.