Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer

NCT ID: NCT02516995

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-07-31

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).

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Patients with prostate cancer

Group Type: EXPERIMENTAL

Functional magnetic resonance imaging

Intervention Type: DEVICE

Ultrasound

Intervention Type: DEVICE

Interventions

Functional magnetic resonance imaging

Intervention Type: DEVICE

Ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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)

1. pacemaker, other electronic appliance (depending on model);

2. heart valve, intra-cranial clip aneurysm, cerebral ventricular bypass valve (depending on model);

3. intraocular metallic foreign bodies (chips), and other locations, according to the site to discuss.

4. metal tracheostomy cannula;

5. endovascular stent or vascular embolization coils placed within six weeks in advance;

6. the impediments to a long examination with spectroscopy sequence of ten to twenty minutes: major tremors, inability to lie more than 30 minutes;

7. local sources of magnetic distortion which is sensitive spectroscopic imaging: hip replacement, prostate biopsy older than six weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, France

Countries

France

Other Identifiers

2010/1630

Identifier Type: OTHER

Identifier Source: secondary_id

2010-A00440-39

Identifier Type: -

Identifier Source: org_study_id