Radiation Exposure Awareness From Patients Undergoing Nuclear Medicine Diagnostic Scans (REA)

June 28, 2018 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital NHS Trust Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group 1: patients attending 99mTc-MDP bone scans. Group 2: patients attending 18F- FDG PET/CT scans.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Previous participation in one group; (participants can only take part in one of the group questionnaires once).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Self-administered questionnaire
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 .
Other: Self-administered questionnaire
Self-administered questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative assessment on current leaflets for bone scans and FDG PET/CT scans
Time Frame: 9 months
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.
9 months
Demographic correlations with self-reported knowledge
Time Frame: 9 months
Statistical correlations with age, gender, previous scans, level of education, confidence in completing medical forms and self-reported knowledge.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Marsden NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
City, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCR 4835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

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