Clinical trial · Interventional
Intra-Operative Dural Brachytherapy With Yttrium-90 Plaque Applicators
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): New device for dural plaque irradiation was approved by FDA.
Summary
Brief summary (as posted)
The purpose of this clinical trial is to determine the feasibility of the Y-90 plaque applicator. The Y-90 plaque application is designed to deliver high doses of radiation to tumors in the spine that involve dura (the tough outer layer of the spinal cord). Tumors in the spine need a high dose of radiation to kill cancer cells. The nearby spinal cord is a sensitive area which does not safely tolerate high doses of radiation. The Y-90 plaque applicator is a special technique used to deliver the radiation dose to the tumor cells and avoid the spinal cord.
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 |
|---|---|---|---|
| Spinal Neoplasms | Spinal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90 Plaque Applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dural brachytherapy plaque
- description
- Patients undergoing spine tumor resection will undergo dural plaque brachytherapy.
- interventionNames
- Device: Yttrium-90 Plaque Applicator
Primary outcomes (1)
- measure
- Number of Participants With Successful Titanium-enclosed and Differentially-loaded Y-90 Dural Brachytherapy Plaque Fabrication and Use
- timeFrame
- At time of procedure
Secondary outcomes (2)
- measure
- Number of Participants With Local Control
- timeFrame
- at 6 weeks and at three months after therapy, and every 6 months thereafter for four years, and then annually to year 10
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of malignant tumor involving spine with extraosseous extension or arising in paraspinal soft tissues with tumor involving or abutting the dura. Patients with a limited metastatic disease and tumor involving the spine or paraspinal soft tissues and who are judged to benefit from surgery will also be eligible. * Lesion may be primary or recurrent after prior surgery * No clinical, radiographic or other evidence of distant metastatic tumor * Fit for receiving the planned radiation dose to the affected site. No known genetic disease or medical condition associated with an abnormal radiation sensitivity. * 18 years of age or older * KPS of 70 or greater (excluding consideration of poor function due to the local growth or systemic metabolic effects of the tumor Exclusion Criteria: * Disease/conditions characterized by high radiation sensitivity * Pregnancy * Evidence of cord/cauda malfunction for causes other than effect os local tumor growth or due to metabolic effects of tumor
References
Publications (0)
Data not yet available