Ignite Creation Date:
2025-12-18 @ 8:36 AM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT03458585
Status:
None
Last Update Posted:
2018-06-29 00:00:00
First Post:
2018-02-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic Scans
Sponsor:
None
Organization:
Study Overview
Official Title:
Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic 99mTc-MDP Bone Scans and 18F-FDG PET/CT Scans
Status:
None
Status Verified Date:
2018-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
REA
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: