Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping (SPECT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00608920|
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment|
|Adenocarcinoma of the Prostate||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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer|
|Study Start Date :||March 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
Experimental: SPECT lymph node mapping
||Other: Single Photon Emission Computed Tomography (SPECT)|
- Determine the feasibility of using SPECT-LM [ Time Frame: Completion of enrollment of all patients ]
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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|