A Phase 1 interventional study of Fiducial marker placement in Prostate Cancer and Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Diagnostic
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 15 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
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EXCLUSION CRITERIA:
Patients with contraindication to transrectal needle placement:
Patients with contraindications to MRI:
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
Procedure: Fiducial marker placement
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
To test the hypothesis that MRI guidance allows for accurate fiducial marker placement within the prostate
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To determine the toxicity of MR-Guided fiducial marker placement
Time frame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
To gain preliminary experience using intraprostatic fiducial markers for daily set-up assessment and adjustment of external radiation beam targeting.
Time frame: completion of study
To gain preliminary experience using intraprostatic fiducial markers for image fusion.
Time frame: completion of study
To measure the magnitude of marker migration during the course of radiotherapy.
Time frame: completion of study
To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.
Time frame: completion of study
To gather data on the feasibility, tolerability, and effectiveness of local anesthetic injection along the neurovascular bundle under MRI guidance.
Time frame: completion of study
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)