PRIME - PRostate Imaging for Margin Evaluation

Prostatic Neoplasms Clinical Trial

— PRIME  

Official title:

A Feasibility Study to Evaluate 18F-choline Cerenkov Luminescence Imaging for Measuring Margin Status in Radical Prostatectomy Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151097
• Other study ID #: LPM-003
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: June 22, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Lightpoint Medical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
United Kingdom	University College Hospital London	London

Sponsors (3)

Lead Sponsor	Collaborator
Lightpoint Medical Limited	University College London Hospitals, University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiation dosimetry to staff	Radiation dosimetry results will be used to assess the feasibility of following routine procedures for care of patients and handling of surgical specimens in patients undergoing prostatectomy following administration of 18F-choline.	Intra and immediate post-operative	Yes
Primary	Margin status of prostatectomy specimen as determined by the LightPathTM Imaging System	Use of the LightPathTM Imaging System will be examined in order to assess the feasibility of using CLI for determining margin status intraoperatively.	Intra-operative	No
Secondary	The agreement between margin status as determined by CLI and histopathology	Tumour margin status of prostatectomy specimens as determined by CLI and routine histopathology analysis will be compared in order to assess the performance of the LightPathTM Imaging System for determining margin status intraoperatively.	Intra and immediate post-operative	No