NCT03920371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 13, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

April 18, 2019

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

January 16, 2017

Last Update Submit

April 17, 2019

Conditions

Tumour

Keywords

small field of viewhybrid compact gamma camerahandheld gamma camera

Outcome Measures

Primary Outcomes (1)

  • Agreement of the visualisation of radiopharmaceutical uptake between the hybrid gamma camera and the standard clinical gamma camera for the sites investigated.

    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.

    1 year

Secondary Outcomes (1)

  • The clinical optimisation of the hybrid gamma camera image display

    1 year

Study Arms (1)

gamma camera imaging

EXPERIMENTAL

hand held camera

Other: gamma camera imaging

Interventions

gamma camera imagingOTHER

Following the administration of the routine radiopharmaceutical and the standard wait before clinical diagnostic imaging, additional research gamma camera imaging is carried out

gamma camera imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, LE1 7RH, United Kingdom

Location

Related Publications (4)

  • Ng AH, Clay D, Blackshaw PE, Bugby SL, Morgan PS, Lees JE, Perkins AC. Assessment of the performance of small field of view gamma cameras for sentinel node imaging. Nucl Med Commun. 2015 Nov;36(11):1134-42. doi: 10.1097/MNM.0000000000000377.

    PMID: 26352214BACKGROUND

  • Bugby SL, Lees JE, Bhatia BS, Perkins AC. Characterisation of a high resolution small field of view portable gamma camera. Phys Med. 2014 May;30(3):331-9. doi: 10.1016/j.ejmp.2013.10.004. Epub 2013 Nov 10.

    PMID: 24225012BACKGROUND

  • Bhatia BS, Bugby SL, Lees JE, Perkins AC. A scheme for assessing the performance characteristics of small field-of-view gamma cameras. Phys Med. 2015 Feb;31(1):98-103. doi: 10.1016/j.ejmp.2014.08.004. Epub 2014 Nov 13.

    PMID: 25440940BACKGROUND

  • Lees, J.E., S.L. Bugby, B.S. Bhatia, L.K. Jambi, M.S. Alqahtani, W.R. McKnight, A.H. Ng, and A.C. Perkins, A small field of view camera for hybrid gamma and optical imaging. Journal of Instrumentation, 2014. 9(12): p. C12020-C12020.

    BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • John E Lees, PhD

    University of Leicester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2017

First Posted

April 18, 2019

Study Start

June 13, 2017

Primary Completion

September 10, 2018

Study Completion

September 10, 2018

Last Updated

April 18, 2019

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)