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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

John E Lees, PhD

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.

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.

Evaluation of a Prototype Hand Held Hybrid Gamma Camera

Extended Pilot Evaluation of a Prototype Hand Held Hybrid Gamma Camera

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.

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.

Nottingham University Hospitals NHS Trust

University of Nottingham

University of Leicester

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Acquisition of images using the camera as additional steps to the standard SLNB procedures.

Hybrid optical-gamma imaging

Kwok Leung Cheung

A novel hand held hybrid optical-gamma camera (hereinafter referred to as the "camera") has been developed and can be used to image radiotracer distribution at the patient bedside. This study aims to evaluate the imaging capabilities of the camera in patients attending surgery for sentinel lymph node biopsy (SLNB) procedure. It is anticipated that this could improve the accuracy and simplify sentinel lymph node detection by providing fused optical and gamma imaging.

This is a single centre prospective, non-randomised and non-blinded research project using the camera in the operating theatre in addition to the standard gamma surgical probe for assessing lymph node involvement in breast cancer patients undergoing surgery for their disease. The duration of the study is 1 year.

The purpose of the trial will be to determine if the camera can be used for the localisation of sentinel lymph nodes during the SLNB procedure and to compare detection rates of sentinel lymph node(s) with the standard method using the gamma probe.

Study Plan:

This study will not alter the standard SLNB procedures provided by the healthcare provider. The camera will be used to acquire images in the axillary and parasternal regions as additional steps to the standard SLNB procedures. No invasive actions are performed. Images obtained using the camera in this study will include gamma, optical and fused gamma/optical images in each acquisition. In additional to the intraoperative imaging study using the camera system, a subjective assessment by questionnaire will be carried out amongst the surgeons to obtain their feedback.

Statistics:

For the quantitative analysis, the distribution of continuous variables will be summarised using mean and standard deviation (if normally distributed) or median and range (if not normally distributed); distribution of categorical variables will be summarised by presenting the number and percentages that falling into each categories. Missing data will be recorded. SPSS will be used to manage the data. The detection rate of both detection methods (camera versus standard techniques) will be tabulated as binary data (yes/no). Validity analysis will be computed for sensitivity, specificity, positive predictive value and negative predictive value. Also Kappa (categorical data) method will be used to examine the agreement between two methods. Good agreement will be claimed if the value of kappa between 0.81 and 1.00.

Sample size:

The calculated sample size is 53 participants. It has been calculated using nQuery Advisor® 6.0 with the goal to make conclusion using agreement. The sample size has the 80% power to pick up ҡ1 = 0.410 or greater.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of a Prototype Hand Held Hybrid Gamma Camera	NCT03920371	Tumour	gamma camera im...	18 Years -	University of Leicester
Hybrid Gamma Camera in Breast Surgery	NCT02621099	Breast Cancer	Hybrid optical-...	18 Years -	University of Nottingham
Hybrid Gamma Camera in Breast Surgery	NCT02621099	Breast Cancer	Hybrid optical-...	18 Years -	University of Nottingham

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