Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Adenocarcinoma of the Prostate |
Other: Single Photon Emission Computed Tomography (SPECT) |
| Study Type: | Interventional |
| 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
| Enrollment: | 15 |
| Study Start Date: | March 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: SPECT lymph node mapping
|
Other: Single Photon Emission Computed Tomography (SPECT) |
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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-
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00608920 History of Changes |
| Other Study ID Numbers: | 06-0772 |
| Study First Received: | January 2, 2008 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Washington University School of Medicine:
|
SPECT |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013