Evaluation of a Prototype Hand Held Hybrid Gamma Camera (BIVISTA)
|ClinicalTrials.gov Identifier: NCT03920371|
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tumour||Other: gamma camera imaging||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Pilot Evaluation of a Prototype Hand Held Hybrid Gamma Camera|
|Actual Study Start Date :||June 13, 2017|
|Actual Primary Completion Date :||September 10, 2018|
|Actual Study Completion Date :||September 10, 2018|
Experimental: gamma camera imaging
hand held camera
Other: gamma 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
- Agreement of the visualisation of radiopharmaceutical uptake between the hybrid gamma camera and the standard clinical gamma camera for the sites investigated. [ Time Frame: 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.
- The clinical optimisation of the hybrid gamma camera image display [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920371
|University of Leicester|
|Leicester, United Kingdom, LE1 7RH|
|Study Director:||John E Lees, PhD||University of Leicester|