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Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping (SPECT)

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ClinicalTrials.gov Identifier: NCT00608920
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Other: Single Photon Emission Computed Tomography (SPECT) Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
Study Start Date : March 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SPECT lymph node mapping
  1. Diagnostic pelvic CT
  2. Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation
  3. CT simulation (2 hours after prostate markers are placed)
  4. SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection)
Other: Single Photon Emission Computed Tomography (SPECT)



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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 ]
    1. Greatest radial distance of lymphatic channel volume from vessel wall contour
    2. Fraction of lymphatic channel volume, normal tissue volume, and critical structure volumes included in radial expansions from vessel wall



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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-

Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeff Michalski, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00608920     History of Changes
Other Study ID Numbers: 06-0772
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

Keywords provided by Washington University School of Medicine:
SPECT

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases