Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CivaSheet.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device CivaSheet
implanting CivaSheet for localized radiation dose delivery
Primary outcome measures
- Local Control Rate at 1 year [Time frame: 1 year]
Secondary outcome measures (3)
- Freedom from regional or distant recurrence [Time frame: 1 year]
- Time to recurrence [Time frame: 1 year]
- Toxicity graded on CTCAE 4.0 Scale [Time frame: 1 year]
Eligibility criteria
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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT03290534 · CT006