NCT02516995

Brief Summary

Merge the data of ultrasound with that of the anatomical and functional MRI is necessary since the high dose rate Curietherapy is carried out under ultrasound guidance. The investigators will recruit prostate cancer patients to evaluate the quality of the data, their sensitivity to exam conditions (patient position, volume of endorectal probe, gold grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from different sources with the purpose of estimating the opportunities of integration treatment plan for Curietherapy broadband. The nuclear magnetic resonance imaging provides precise anatomical study, but also provides access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context, involving close collaboration between clinicians, medical physicists, and physicists of the teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

August 3, 2015

Last Update Submit

February 9, 2016

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of imaging [good/good enough/not good enough]

    Assessed six weeks after inclusion

Study Arms (1)

Patients with prostate cancer

EXPERIMENTAL
Device: Functional magnetic resonance imagingDevice: Ultrasound

Interventions

Functional magnetic resonance imagingDEVICE
Patients with prostate cancer
UltrasoundDEVICE
Patients with prostate cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prostate cancer biopsy-proven, intermediate or high risk (according to D'Amico Classification), for which radiotherapy is indicated.
  • Accepting the imaging tests.
  • Age \<70 years.
  • Informed consent signed.

You may not qualify if:

  • Mental pathology that can interfere with the proper conduct of the study;
  • Claustrophobia;
  • Severe heart or respiratory disorder that can make it difficult to achieve relatively long imaging tests
  • Contraindications to magnetic resonance imaging (MRI)
  • pacemaker, other electronic appliance (depending on model);
  • heart valve, intra-cranial clip aneurysm, cerebral ventricular bypass valve (depending on model);
  • intraocular metallic foreign bodies (chips), and other locations, according to the site to discuss.
  • metal tracheostomy cannula;
  • endovascular stent or vascular embolization coils placed within six weeks in advance;
  • the impediments to a long examination with spectroscopy sequence of ten to twenty minutes: major tremors, inability to lie more than 30 minutes;
  • local sources of magnetic distortion which is sensitive spectroscopic imaging: hip replacement, prostate biopsy older than six weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance ImagingUltrasonography

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 6, 2015

Study Start

August 1, 2010

Primary Completion

June 1, 2013

Study Completion

July 1, 2014

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

FR(1)