Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03290534

Enrollment

Registered

2017-09-25

Start date

2019-03-13

Completion date

2027-12-31

Last updated

2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Lung Cancer Stage I, Lung Cancer Stage II

Keywords

wedge resection, sublobar resection, brachytherapy, CivaSheet, Pd-103, CivaTech Oncology, lung cancer, lung

Brief summary

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

DEVICECivaSheet

implanting CivaSheet for localized radiation dose delivery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Local Control Rate at 1 year	1 year	The local control rate in the region irradiated by CivaSheet.

Secondary

Measure	Time frame	Description
Freedom from regional or distant recurrence	1 year	Control rate for recurrences outside the local area irradiated by CivaSheet.
Time to recurrence	1 year	Time in months to any recurrence
Toxicity graded on CTCAE 4.0 Scale	1 year	pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026