|
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment Clinical research trials and Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment. Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment clinical trial. Subjects frequently get the best healthcare possible for their Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "U" Clinical Trials Conditions > Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment  Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
For Condition: Prostatic Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: To effectively treat prostate cancer, doctors need an accurate view (via X-rays) of the prostate gland during radiation therapy. To help improve this view, doctors may insert gold markers called fiducials into the prostate by placing hollow gold needles through the rectum and moving a fiducial through each needle. The purpose of the study is to determine whether an MRI scan can help doctors improve their placement of these needles. Fifteen men will participate in this study. Patients will take the antibiotic levofloxacin for two days prior to the placement of the fiducials, then will have a small enema and another dose of the antibiotic on the morning of the procedure. After being anesthetized, patients will have an antenna-like tube placed into the rectum and have MRI images taken of the area. The doctor will then use these scans to place four fiducials into the prostate. The procedure will require approximately 45 minutes. Patients will be allowed to go home the same day of the procedure, which will be followed by a seven-week course of standard radiation therapy. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, blood work, urine tests, and, if appropriate, an MRI or bone scan.
Details: Effective image-guided prostate therapies require excellent visualization of the prostate and surrounding anatomy, such that cancerous tissue can be treated while avoiding nearby neural and vascular structures. As such, Magnetic Resonance Imaging is well suited for image-guidance because of its excellent soft tissue contrast, multiplanar capabilities, and the potential to yield spectral/biological tumor mapping. Despite the potential for MRI-guided prostate therapies, there are currently no techniques that allow for precise trans-rectal intraprostatic needle placement in patients. In this pilot study we seek to validate the accuracy and tolerability of a new system and technique that allows for accurate placement of needles within the prostate based upon MR images. The method is very similar to transrectal ultrasound guided biopsy of the prostate, except that it is applicable within a closed high-field MRI scanner. Four gold fiducial markers will be placed within the prostate under needle guidance in a series of patients with localized prostate cancer before external beam radiotherapy. Fifteen patients will be enrolled onto this study with sample size determined to obtain reasonably precise estimates of mean placement accuracy. The accrual period is expected to be less than a year. While placement of the fiducial markers has no direct therapeutic benefit for the patient, intraprostatic radiopaque fiducial markers (placed under ultrasound) have shown value in assessing daily setup errors and off-line organ motion during external beam radiation therapy for prostate cancer. Therefore, a secondary objective is to gain experience using these intraprostatic fiducial markers for daily assessment and adjustment of external radiation beam targeting. These markers can also be utilized to aid in CT-MRI fusion and results in better target delineation for treatment planning. In this way, prostate cancer patients who are receiving external-beam radiation therapy may benefit from participation.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: Pathologically confirmed adenocarcinoma of the prostate gland. Age greater than or equal to 18 years. ECOG performance status of 0 or 1. Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility). EXCLUSION CRITERIA: Patients with contraindication to transrectal needle placement: -Bleeding disorder; -PT/PTT greater than 1.5.times the upper limit of normal; -Platelets less than 50K; -Artificial heart valve. Patients with contraindications to MRI: -Patients weighing greater than 136 kg (weight limit for scanner table); -Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or implanted electronic devices. Patients with chronic inflammatory bowel disease. Patients with distant metastatic disease. Patients with a prior history of pelvic or prostate radiotherapy. Cognitively impaired patients who cannot give informed consent. Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations, procedures, and high-dose external beam radiotherapy.
Total Enrollment: 15
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030190; 03-C-0190
Study Start Date: May 21, 2003
Record last reviewed: April 21, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061347
Other Prostatic Neoplasms Studies:
1. A Phase I Study of Recombinant Vaccinia Virus that Expresses Prostate Specific Antigen in Adult Patients with Adenocarcinoma of the Prostate
2. Study of Prostate Cancer in Black and White U.S. Veterans
3. Comparison PSA Vaccine Alone or Vaccine with Docetaxel for Treating Prostate Cancer
4. EPO906 Therapy in Patients with Prostate Cancer
5. Study of SGN-15, Antibody-Drug Conjugate, to Treat Hormone Refractory Prostate Cancer
Related Studies:
Other Prostatic Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
|
|
|
|
|
|
|
|
