Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCivaTech Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
CivaSheet
Deviceimplanting CivaSheet for localized radiation dose delivery
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: CivaSheet Directional LDR BrachytherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Local Control Rate at 1 year
The local control rate in the region irradiated by CivaSheet.
Time frame
1 yearSecondary outcomes
1
Freedom from regional or distant recurrence
Control rate for recurrences outside the local area irradiated by CivaSheet.
Time frame
1 year2
Time to recurrence
Time in months to any recurrence
Time frame
1 year3
Toxicity graded on CTCAE 4.0 Scale
pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov