Evaluation of a Prototype Hand Held Hybrid Gamma Camera

Not Applicable

Completed

• Conditions: Tumour
• Interventions: Other: gamma camera imaging

• Registration Number: NCT03920371
• Lead Sponsor: University of Leicester

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.

Study Timeline

• Study First Submitted: 2017-01-16
• Study Start: 2017-06-13
• Status Verified: 2018-05
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gamma camera imaging	gamma camera imaging	hand held camera

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Leicester; 🇬🇧 Leicester, United Kingdom