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

May 22, 2013 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Completion of enrollment of all patients

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Completion of enrollment of all patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Jeff Michalski, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 22, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-0772

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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