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Evaluation of a Prototype Hand Held Hybrid Gamma Camera (BIVISTA)

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ClinicalTrials.gov Identifier: NCT03920371
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
University of Nottingham
Information provided by (Responsible Party):
University of Leicester

Tracking Information
First Submitted Date  ICMJE January 16, 2017
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE June 13, 2017
Actual Primary Completion Date September 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Prototype Hand Held Hybrid Gamma Camera
Official Title  ICMJE Extended Pilot Evaluation of a Prototype Hand Held Hybrid 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Tumour
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: gamma camera imaging
hand held camera
Intervention: Other: gamma camera imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 10, 2018
Actual Primary Completion Date September 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920371
Other Study ID Numbers  ICMJE 0591
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Leicester
Study Sponsor  ICMJE University of Leicester
Collaborators  ICMJE
  • Nottingham University Hospitals NHS Trust
  • University of Nottingham
Investigators  ICMJE
Study Director: John E Lees, PhD University of Leicester
PRS Account University of Leicester
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP