Hybrid Gamma Camera in Breast Surgery

NCT ID: NCT02621099

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Hybrid optical-gamma imaging

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Female
• Age > 18 years
• Scheduled for a Sentinel Lymph Node Biopsy procedure for breast cancer
• Has capacity to provide written 'informed consent'

Exclusion Criteria

Non-English speaking patients who have had:

• a nuclear medicine procedure with administration of a radiopharmaceutical within 72 hours prior to the procedure;
• prior systemic therapy for the breast cancer being scheduled for sentinel node biopsy (e.g. neoadjuvant chemotherapy and primary endocrine therapy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Innovate UK

OTHER_GOV

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwok Leung Cheung

Role: STUDY_CHAIR

University of Nottingham

Locations

Royal Derby Hospital

Derby, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 26352214 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24225012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25440940 (View on PubMed)

Lees, J.E., et al., A small field of view camera for hybrid gamma and optical imaging. Journal of Instrumentation, 2014. 9: p. C12020.

Reference Type: BACKGROUND

Lees, J.E., et al., A high resolution Small Field Of View (SFOV) gamma camera: a columnar scintillator coated CCD imager for medical applications. Journal of Instrumentation, 2011. 6.

Reference Type: BACKGROUND

Other Identifiers

15096

Identifier Type: -

Identifier Source: org_study_id