Tumour
Conditions
Keywords
small field of view, hybrid compact gamma camera, handheld gamma camera
Brief summary
The aim of the project is to undertake clinical development of a hybrid compact gamma camera that combines gamma ray and optical imaging. It is an extension of the previous pilot study using a newly developed handheld hybrid compact gamma camera in clinical arena.
Detailed description
This is a single visit study involving patients who have been referred to the Nuclear Medicine Clinic at Nottingham University Hospitals as part of a standard diagnostic test. Each patient's participation will be approximately 30 minutes and not normally longer than one hour. The study will run for 11 months commencing February 2017 and ceasing at the end of December 2017. As part of their routine care, patients will be sent a letter booking their diagnostic test through a Nuclear Medicine Clinic. Once they have confirmed that they will be attending this diagnostic test, one of the clinical study team trained to take consent will contact the patient by phone. At this point they will be informed of the reason for the study, why they have been approached and the study schedule. If they express interest in participating they will then be sent a copy of the patient informed consent forms. They will be given a minimum of 24 hours before formally signing consent at the study site immediately before participating. Study plan: Following the administration of the routine radiopharmaceutical and the standard wait before clinical diagnostic imaging, the patient will have research images acquired using the hybrid prototype gamma camera. All research images will be anonymised and the additional imaging performed as part of this study will fit in with the patient and the diagnostic test schedules. Should the patient wish to stop at any point, the research study procedure will be terminated. Once these images have been acquired then the patient will go home or proceed with the requirements of their diagnostic test. 75 participants will be recruited for this study.
Interventions
OTHERgamma camera imaging
Following the administration of the routine radiopharmaceutical and the standard wait before clinical diagnostic imaging, additional research gamma camera imaging is carried out
Sponsors
Nottingham University Hospitals NHS Trust
University of Nottingham
University of Leicester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study; * Male or Female, aged 18 years or above; * Be able to understand the study, willing to co-operate with the study procedures and able to attend the study assessment; * Have been administered a radiopharmaceutical as part of a diagnostic test.
Exclusion criteria
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study; * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study; * Patients who have had a nuclear medicine procedure with administration of a radiopharmaceutical within 72 hours prior to the procedure. * Patients who do not speak or understand English (since no translator will be available).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of the visualisation of radiopharmaceutical uptake between the hybrid gamma camera and the standard clinical gamma camera for the sites investigated. | 1 year | The subjective assessment of scintigraphic images obtained using the hybrid camera under test and the standard clinical gamma camera. The image data will be didvdiid into the different exam types and scored using a 3 point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The clinical optimisation of the hybrid gamma camera image display | 1 year | Following subjective assessment of the recorded images the data set will be reviewed by experienced observers and the display fusion will be modified to obtain the clearest visualisation of radiopharmaceutical uptake. |
Countries
United Kingdom
Outcome results
None listed