Hybrid Gamma Camera in Breast Surgery

NCT02621099 | Withdrawn

• 1 other identifier: 15096
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

handheld gamma camera

Outcome Measures

Primary Outcomes (1)

• Agreement of detection rate between the camera and standard gamma probe in the SLNB

  12 months

Secondary Outcomes (3)

• Symmetry of detection rate between the camera and gamma probe in the SLNB

  12 months

• Additional information obtained by the camera in the SLNB

  12 months

• Additional information on internal mammary node detection

  12 months

Interventions

Hybrid optical-gamma imaging DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients scheduled for a sentinel lymph node biopsy (SLNB) procedure for breast cancer

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nottingham: lead
• Innovate UK: collaborator

Study Sites (1)

Royal Derby Hospital

Derby, DE22 3DT, United Kingdom

Location

Related Publications (5)

• 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: 26352214 BACKGROUND

• 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: 24225012 BACKGROUND

• 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: 25440940 BACKGROUND

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

  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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kwok Leung Cheung

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

GB (1)