Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping

NCT00608920 | Completed

• 1 other identifier: 06-0772
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma of the Prostate

Keywords

SPECT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Evaluate the extent to which current target delineation guidelines include actual lymphatic channels visualized on SPECT-LM in the study population.

  Completion of enrollment of all patients

Study Arms (1)

SPECT lymph node mapping

EXPERIMENTAL

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)

Interventions

Single Photon Emission Computed Tomography (SPECT) OTHER

SPECT lymph node mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• History of radical prostatectomy
• History of prior pelvic radiation-

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Jeff Michalski, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: February 6, 2008
• Study Start: March 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

US (1)