- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00061347
Using Fiducial Markers to Aid in Prostate Cancer Radiation Treatment
Trans-Rectal Placement of Prostatic Fiducial Markers Under MR-Guidance in Patients Receiving External Beam Radiotherapy for Prostate Cancer: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
|
Placement of fidicual markers under MRI guidance for localization of radiaiton treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
1, 3, 6, 12, 18, 24, 36, 48, and 60 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
completion of study
|
To gain preliminary experience using intraprostatic fiducial markers for image fusion.
Time Frame: completion of study
|
completion of study
|
To measure the magnitude of marker migration during the course of radiotherapy.
Time Frame: completion of study
|
completion of study
|
To gather data on radiation therapy effects on prostate cancer patients treated at the NCI ROB.
Time Frame: completion of study
|
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
|
completion of study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yu KK, Hricak H. Imaging prostate cancer. Radiol Clin North Am. 2000 Jan;38(1):59-85, viii. doi: 10.1016/s0033-8389(05)70150-0.
- Knopp MV, Weiss E, Sinn HP, Mattern J, Junkermann H, Radeleff J, Magener A, Brix G, Delorme S, Zuna I, van Kaick G. Pathophysiologic basis of contrast enhancement in breast tumors. J Magn Reson Imaging. 1999 Sep;10(3):260-6. doi: 10.1002/(sici)1522-2586(199909)10:33.0.co;2-7.
- Kurhanewicz J, Vigneron DB, Hricak H, Narayan P, Carroll P, Nelson SJ. Three-dimensional H-1 MR spectroscopic imaging of the in situ human prostate with high (0.24-0.7-cm3) spatial resolution. Radiology. 1996 Mar;198(3):795-805. doi: 10.1148/radiology.198.3.8628874.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030190
- 03-C-0190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
Clinical Trials on Fiducial marker placement
-
Cedars-Sinai Medical CenterNational Cancer Institute (NCI)RecruitingNeoplasms | Urologic Neoplasms | Urinary Bladder Diseases | Bladder Cancer | Urinary Bladder NeoplasmUnited States
-
Centre Hospitalier Universitaire VaudoisRecruitingLung Cancer | Lung Metastases | RadiotherapySwitzerland
-
Milton S. Hershey Medical CenterRecruiting
-
Centre hospitalier de l'Université de Montréal...Not yet recruiting
-
Hospital St. Joseph, Marseille, FranceNOVATECH SARecruiting
-
Société Française d'Endoscopie DigestiveCook Group IncorporatedCompletedRectal Neoplasms | Esophageal NeoplasmFrance
-
John Chang, MDUnknownProstate AdenocarcinomaUnited States
-
Centre Georges Francois LeclercTerminated
-
University of FloridaTerminatedCancerUnited States
-
Mount Carmel Health SystemMount Carmel FoundationRecruitingGestational DiabetesUnited States