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

Primary Purpose

Adenocarcinoma of the Prostate

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Photon Emission Computed Tomography (SPECT)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenocarcinoma of the Prostate focused on measuring SPECT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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-

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPECT lymph node mapping

Arm Description

Diagnostic pelvic CT Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation CT simulation (2 hours after prostate markers are placed) SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection)

Outcomes

Primary Outcome Measures

Determine the feasibility of using SPECT-LM
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

Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.
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

Full Information

First Posted
January 2, 2008
Last Updated
May 22, 2013
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00608920
Brief Title
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
Acronym
SPECT
Official Title
SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate
Keywords
SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPECT lymph node mapping
Arm Type
Experimental
Arm Description
Diagnostic pelvic CT Nuclear tracer injection (Tc-99m) - same time as the ACCULOC seed implantation CT simulation (2 hours after prostate markers are placed) SPECT lymphoscintigraphy (first set of images 3-6 hours after injection and second set may be obtained 18-24 hours after injection)
Intervention Type
Other
Intervention Name(s)
Single Photon Emission Computed Tomography (SPECT)
Primary Outcome Measure Information:
Title
Determine the feasibility of using SPECT-LM
Description
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.
Time Frame
Completion of enrollment of all patients
Secondary Outcome Measure Information:
Title
Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.
Description
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
Time Frame
Completion of enrollment of all patients

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Michalski, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

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