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SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer

18 Years
Not Enrolling
Adenocarcinoma of the Prostate

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Trial Information

SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer

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

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

- 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-

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the feasibility of using SPECT-LM

Outcome 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.

Outcome Time Frame:

Completion of enrollment of all patients

Safety Issue:


Principal Investigator

Jeff Michalski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

April 2009

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms



Washington University School of MedicineSaint Louis, Missouri  63110