Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

Adenocarcinoma of the Prostate Clinical Trial

— SPECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608920
• Other study ID #: 06-0772
• Status: Completed
• Phase: N/A
• First received: January 2, 2008
• Last updated: May 22, 2013
• Start date: March 2007
• Est. completion date: April 2009

Study information

• Verified date: May 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Other:
• Single Photon Emission Computed Tomography (SPECT)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Completion of enrollment of all patients	Yes
Secondary	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	Completion of enrollment of all patients	No

External Links

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