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Completed

NCT Number: NCT00608920

Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

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.

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Key information

Conditions

Adenocarcinoma of the Prostate

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Single Photon Emission Computed Tomography (SPECT)

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    • 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: SPECT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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