Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

NCT ID: NCT00608920

Last Updated: 2013-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-04-30

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

Conditions

Adenocarcinoma of the Prostate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Single Photon Emission Computed Tomography (SPECT)

Intervention Type: OTHER

Interventions

Single Photon Emission Computed Tomography (SPECT)

Intervention Type: OTHER

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-

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff Michalski, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

06-0772

Identifier Type: -

Identifier Source: org_study_id