Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
The purpose of this study is to determine if the planning of radiation treatment of prostate cancer patient can be made more precise by comparing currently planning techniques to an imaging technique called SPECT.
Adenocarcinoma of the Prostate
Other: Single Photon Emission Computed Tomography (SPECT)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer|
- Determine the feasibility of using SPECT-LM [ Time Frame: Completion of enrollment of all patients ] [ Designated as safety issue: Yes ]
Safety: The study will be feasible if no more than 80% of patients experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction to Tc99.
Efficacy: The study will be feasible if at least 80% of patients have at least one identifiable lymph node on SPECT-LM.
- Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population. [ Time Frame: Completion of enrollment of all patients ] [ Designated as safety issue: No ]
- Greatest radial distance of lymphatic channel volume from vessel wall contour
- Fraction of lymphatic channel volume, normal tissue volume, and critical structure volumes included in radial expansions from vessel wall
|Study Start Date:||March 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
Experimental: SPECT lymph node mapping
||Other: Single Photon Emission Computed Tomography (SPECT)|
Single photon emission computed tomography (SPECT) uses radioactive tracers and a scanner to record data that a computer constructs into two- or three-dimensional images. A small amount of a radioactive drug is injected into the body and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. Using a gamma camera (a special kind of scanner), we can create a better picture of the lymph node region. We will compare these pictures to images from your CT scan, to help plan your therapy.
The research in this study involves seeing if it is feasible to use SPECT scanning procedures for the purpose of planning your radiation treatment. We hope that doing so will allow us to more accurately and precisely plan radiation treatment to potential sites of cancer, and avoid delivering too much radiation to normal
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608920
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Jeff Michalski, M.D.||Washington University School of Medicine|