Clinical trial · Interventional
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
NCT03290534CI-TRIAL-00088125recruitingPhase 2ClinicalTrials.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 is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Stage I | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Lung Cancer Stage II | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CivaSheet | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CivaSheet Directional LDR Brachytherapy
- description
- FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
- interventionNames
- Device: CivaSheet
Primary outcomes (1)
- measure
- Local Control Rate at 1 year
- timeFrame
- 1 year
- description
- The local control rate in the region irradiated by CivaSheet.
Secondary outcomes (3)
- measure
- Freedom from regional or distant recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject signed inform consent * Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung * Pre-operative criteria * Lung nodule suspicious for NSCLC * Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen * Clinical stage I or Clinical stage II * Not pregnant or nursing * Negative pregnancy test in premenopausal women * Fertile patients must use effective contraception * More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.