Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging – Protocol II

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Aalborg Universityhospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aalborg Universityhospital
ClinicalTrials.gov Identifier:
NCT00250224
First received: November 7, 2005
Last updated: May 9, 2006
Last verified: September 2005
  Purpose

A new method for localization of the prostate during external beam radiotherapy. The method is based on insertion of a new thermo-expandable Ni-Ti stent. The radiological properties of the stent are used for precise prostate localization during treatment using electronic portal images


Condition Intervention Phase
Prostatic Neoplasms
Device: Radiotherapy stent
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostate Localization During Radiotherapy Using a Ni-Ti Stent and Electronic Portal Imaging – Protocol II

Resource links provided by NLM:


Further study details as provided by Aalborg Universityhospital:

Primary Outcome Measures:
  • stent in situ during radiotherapy

Estimated Enrollment: 30
Study Start Date: January 2006
Estimated Study Completion Date: December 2006
Detailed Description:

Inclusion criteria’s in the study were 1) Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used). 2) Patients should consequently be candidates for intended curative radiotherapy. Prostatic work up is done before inclusion in the study. A new prostatic Nickel - Titanium stent is placed in the prostatic urethra one week prior to the radiotherapy planning CT using a flexible cystoscope to insert the stent under urethral anaesthesia. The stent is then flushed with hot water (60 degrees Celsius). The hot water expands the stent collar, thereby locking the stent in place. Correct positioning of the stent is secured visually on retraction of the scope. Radiotherapy of prostate is given to a mean dose of 70 (department standard regime). Treatment are given with daily fractions of 2 Gy using a combination of 6 MV and 18 MV X-ray fields using isocentric 3D conformal treatment plan, consisting of three MLC conformal radiation fields (One anterior and two lateral wedged fields). This was assumed to be the optimal treatment plan. A pair of orthogonal 15 cm x 15 cm isocenter setup fields was added to the plan. The orthogonal fields are used to obtain pairs of electronic portal images. Electronic portal images are recorded using a Varian As500 electronic portal imaging device (EPID). The images are used to determine the 3D reference position of the stent. The image pairs of the stent were taken at eight treatment sessions in each patient (Session number 1,2,3,6,11,21,22 and 23). From each orthogonal set of images the 3D position of both the stent and the symphysis (pubic bone) are determined. Positions are calculated using orthogonal reconstruction. A control CT scan is made before treatment session number 21 to verify the intra prostatic position of the stent. The intra prostatic position of the stent is also verified during removal of the stent three months after radiation therapy. Before removal the stent was flushed with water at 10 degrees Celsius. When cooled with 10°C cold water, the stent became super soft, and can easily be removed as a twisted wire.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients should present with histological verified local or locally advanced PC (stage T2b to T3b, N0, M0; UICC 1992 classification was used).
  2. Patients should consequently be candidates for intended curative radiotherapy -

Exclusion Criteria:

dislocation or removal of stent

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250224

Contacts
Contact: Bente Lund, MD +45 9932 2884 aas.e9t5@nja.dk

Locations
Denmark
Dept of oncology Recruiting
Aalborg, Nordjylland, Denmark, 9000
Contact: Bente Lund, MD    +45 9932 2884    aas.e9t5@nja.dk   
Sponsors and Collaborators
Aalborg Universityhospital
Investigators
Study Chair: Jesper Carl, PhD Dept medical Physics, Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00250224     History of Changes
Other Study ID Numbers: stent02
Study First Received: November 7, 2005
Last Updated: May 9, 2006
Health Authority: Denmark: National Board of Health

Keywords provided by Aalborg Universityhospital:
Radiotherapy
image guided
marker

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

ClinicalTrials.gov processed this record on September 30, 2014