Clinical trial · Observational
An Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
A Prospective Evaluation of Polymer Based Fiducials for Use in Imaging Patients Receiving Treatment for Prostate Cancer
NCT01478412CI-TRIAL-00005884ClarityunknownClinicalTrials.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)
This trial is to determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion, and if alignment correction vectors obtained from ultrasound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
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 |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polymer based fiducial placement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Males with prostate adenocarcinoma
- description
- English speaking males with histologically confirmed prostate adenocarcinoma and diagnosis of low risk or intermediate risk prostate cancer.
- interventionNames
- Other: Polymer based fiducial placement
Primary outcomes (1)
- measure
- Ultrasound versus MRI image fusion for daily prostate positioning
- timeFrame
- 4 months
- description
- Determine if prostate target delineation obtained through an ultrasound based system is equivalent in accuracy to the MRI image fusion method, and if alighment crrection vectors obtained from ultransound imaging are of equivalent accuracy to orthogonal X-ray imaging for daily prostate positioning.
Secondary outcomes (1)
- measure
- Polymer based marker visualization
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * diagnosis of low risk or intermediate risk prostate cancer * approved for proton therapy treatment at CDH ProCure Proton Therapy Center * prescribed and consented for the placement of fiducial markers into the prostate as part of the standard treatment procedure * capable of receiving an MRI of the pelvis region for prostate localization * the prostate gland of eligible patients must be capable of imaging from an anterior trans-abdominal ultrasound as determined by the treating investigator * must be fluent in the English language; must be able to provide written study consent Exclusion Criteria: * Evidence of a large TURP defect per investigator discretion * previous prostate cancer surgery including prostatectomy, hyperthermia and cryosurgery * previous pelvic radiation for prostate cancer * current grade 2 or above incontinence * history of orthopedic procedures in the area of the treatment, specifically no prior hip replacement or procedure in which metallic or high density material remains which would be within stereoscopic kilovoltage imaging area * prior permanent placement of any metallic or high density material within the prostate * known allergy to ultrasonic gel
References
Publications (0)
Data not yet available
No reference posted for this study.