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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376360
Other study ID # QUIP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2015
Est. completion date May 1, 2017

Study information

Verified date November 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 1, 2017
Est. primary completion date May 1, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary correlation between Gleason score and dynamic parameters on PET and MRI study the potential correlation between dynamic parameters on PET and MRI when anatomopathological report is available, an average of 3 months after the PET/CT
Secondary reconstructions on 18F-choline PET determine the mean influx from each reconstruction which is the closest to the objective value when all 18F-choline PET are performed, an average of 6 months
Secondary best "fitting" on PET and MRI the Akaike Criteria Information was chose to choose the best fit when all MRI are performed, an average of 6 months
Secondary comparison between data (PSA, TNM stage, EFS and OS) comparison between data (PSA, TNM stage, EFS and OS) 01/05/2017
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