Clinical trial · Interventional
Single Photon Emission Computed Tomography (SPECT) Lymph Node Mapping
SPECT Lymph Node Mapping to Define Nodal Clinical Target Volume in Patients With Prostate Cancer
NCT00608920CI-TRIAL-00010404SPECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single Photon Emission Computed Tomography (SPECT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SPECT lymph node mapping
- description
- 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)
- interventionNames
- Other: Single Photon Emission Computed Tomography (SPECT)
Primary outcomes (1)
- measure
- Determine the feasibility of using SPECT-LM
- timeFrame
- Completion of enrollment of all patients
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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-
References
Publications (0)
Data not yet available
No reference posted for this study.