Breast Cancer Clinical Trial
— HICAMOfficial title:
First Use of a Hybrid Gamma Camera for Sentinel Lymph Node Localisation in Patients Undergoing Surgery for Primary Breast Cancer
Verified date | May 2017 |
Source | University of Nottingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Derby Hospital | Derby |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham | Innovate UK |
United Kingdom,
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. — View Citation
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. — View Citation
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.
Lees, J.E., et al., A small field of view camera for hybrid gamma and optical imaging. Journal of Instrumentation, 2014. 9: p. C12020.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement of detection rate between the camera and standard gamma probe in the SLNB | 12 months | ||
Secondary | Symmetry of detection rate between the camera and gamma probe in the SLNB | 12 months | ||
Secondary | Additional information obtained by the camera in the SLNB | 12 months | ||
Secondary | Additional information on internal mammary node detection | 12 months |
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