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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00608920 |
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Date of registration:
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02/01/2008 |
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Primary sponsor: |
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Public title:
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Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
SPECT |
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Scientific title:
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SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00608920 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeff Michalski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with biopsy proven adenocarcinoma of the prostate
- Patients with at least one of the following high risk clinical features at the time
of presentation:
- Extra-prostatic extension (on palpation or radiographic imaging)
- PSA = 20
- Gleason Score = 8
- Patients scheduled to receive prostatic and pelvic IMRT with ACCULOC® target
localization
- Age > 18 years
- ECOG Performance Status = 2
- Willing and able to sign informed consent document.-
Exclusion Criteria:
- History of radical prostatectomy
- History of prior pelvic radiation-
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Adenocarcinoma of the Prostate
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Intervention(s)
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Other: Single Photon Emission Computed Tomography (SPECT)
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Primary Outcome(s)
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The study will be feasible if no more than two patients (80%) experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction
[Time Frame: 3 years]
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Secondary Outcome(s)
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o Greatest radial distance of lymphatic channel volume from vessel wall contour o Fraction of lymphatic channel volume, normal tissue volume and critical structure volumes included in radial expansions from vessel wall
[Time Frame: 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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