Functional Medical Imaging Quantization in Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT03376360
• Lead Sponsor: University Hospital, Brest

Brief Summary

Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist.

Several criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy.

Functional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management.

Consequently, the objective of this study were:

* Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer

* Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-18
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

Inclusion Criteria

Patients with prostate cancer histologically proven included in Brest University Hospital between 01/07/2012 and 01/10/2015 and underwent F-choline PET/CT and pelvic MRI Patient consent

Exclusion Criteria

No lesion on dynamic acquisition on PET/CT and/or on pelvic MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation between Gleason score and dynamic parameters on PET and MRI	when anatomopathological report is available, an average of 3 months after the PET/CT	study the potential correlation between dynamic parameters on PET and MRI

Secondary Outcome Measures

Name	Time	Method
reconstructions on 18F-choline PET	when all 18F-choline PET are performed, an average of 6 months	determine the mean influx from each reconstruction which is the closest to the objective value
best "fitting" on PET and MRI	when all MRI are performed, an average of 6 months	the Akaike Criteria Information was chose to choose the best fit
comparison between data (PSA, TNM stage, EFS and OS)	01/05/2017	comparison between data (PSA, TNM stage, EFS and OS)

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France