Clinical trial NCT02151097: PRIME - PRostate Imaging for Margin Evaluation
Official title: A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: Prostatectomy
Prostate cancer
Cerenkov Luminescence Imaging
Lead sponsor: Lightpoint Medical Limited
Sponsor class: INDUSTRY
Collaborators: name: University College London Hospitals
name: University College, London
First posted: 2014-05-30
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or PSA\>20 ng/ml, or Gleason Score 8-10, undergoing radical prostatectomy.

Brief summary: This study will evaluate the feasibility of using intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine tumour margin status. The samples will be imaged using the LightPathTM Imaging System which consists of a light-tight box containing an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM system in clinical practice.

Detailed description: This study is a prospective, single-centre feasibility study to evaluate the use of intra-operative Cerenkov Luminescence Imaging (CLI) of prostatectomy specimens to determine margin status.

Subjects will receive an intravenous injection of 370 Mega Becquerel (MBq) of 18F-choline prior to routine, elective radical prostatectomy. The surgery will be performed according to standard-of-care. The resected prostatectomy specimens will be imaged using the LightPathTM Imaging System, consisting of a light-tight box containing an ultra-sensitive lens and Electron Multiplying Charged-Coupled Device (EMCCD) camera.

This study will measure the agreement between margin status of the prostatectomy specimen as determined by CLI and by histopathology (reference method). This study will assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Men ≥18 years of age diagnosed with high risk prostate cancer, defined as clinical stage ≥T2c, or PSA\>20 ng/ml, or Gleason Score 8-10.
* Patients undergoing radical prostatectomy

Exclusion Criteria:

* Known hypersensitivity to 18F-choline
* Patients currently taking colchicine
* Prior therapy for prostate cancer (e.g. focal therapy)

Primary outcomes:
measure: Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System
timeFrame: Intra-operative
Secondary outcomes:
measure: The agreement between margin status as determined by CLI and histopathology
timeFrame: Intra and immediate post-operative
Other outcomes:
measure: Radiation dosimetry to staff
timeFrame: Intra and immediate post-operative
Locations:
city: London
country: United Kingdom
facility: University College Hospital London
Study officials:
affiliation: Head of Clinical Development, Lightpoint Medical
name: Sheryl O'Farrell, PhD
role: STUDY_DIRECTOR
References: