We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Functional Medical Imaging Quantization in Prostate Cancer (QUIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03376360
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Prostate Cancer

Study Design

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer: Preliminary Results Concerning the Length of the Acquisition
Actual Study Start Date : October 1, 2015
Primary Completion Date : May 1, 2017
Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. correlation between Gleason score and dynamic parameters on PET and MRI [ Time Frame: 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 :
  1. reconstructions on 18F-choline PET [ Time Frame: 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

  2. best "fitting" on PET and MRI [ Time Frame: when all MRI are performed, an average of 6 months ]
    the Akaike Criteria Information was chose to choose the best fit

  3. comparison between data (PSA, TNM stage, EFS and OS) [ Time Frame: 01/05/2017 ]
    comparison between data (PSA, TNM stage, EFS and OS)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376360


Locations
France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03376360     History of Changes
Other Study ID Numbers: QUIP
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
prostate cancer
Fcholine
positron emission tomography
MRI

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases