Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00608920

Purpose

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.

Condition	Intervention
Adenocarcinoma of the Prostate	Other: Single Photon Emission Computed Tomography (SPECT)

MedlinePlus related topics: CT Scans Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

The study will be feasible if no more than two patients (80%) experience the following complications: infection requiring hospitalization or IV antibiotics, urinary retention requiring placement of a Foley catheter, moderate or severe allergic reaction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

o Greatest radial distance of lymphatic channel volume from vessel wall contour o Fraction of lymphatic channel volume, normal tissue volume and critical structure volumes included in radial expansions from vessel wall [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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
Evidence of pelvic lymph nodes greater than 1 cm on diagnostic CT

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608920

Contacts

Contact: Linda M Brockman

(314) 454-7986

brockmal@ccadmin.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sasha Wahab, MA, MD 314-747-9600 swahab@radonc.wustl.edu
Principal Investigator: Sasha Wahab, MA, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Sasha Wahab, MA, MD

Washington University School of Medicine

More Information

Responsible Party:	Washington University School of Medicine ( Sasha Wahab, MA, MD )
Study ID Numbers:	06-0772
Study First Received:	January 2, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00608920
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009