Study on Using a Permanent Implantable Device to Treat Lung Cancer
Sponsor: CivaTech Oncology
ClinicalTrials ID:NCT03290534
This study is exploring a new treatment method for lung cancer using a device that delivers radiation directly to the tumor while minimizing exposure to nearby healthy tissues like the heart.
Patient Parameters
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Program Overview
The purpose of this study is to test a new device that uses a type of radiation therapy called brachytherapy to treat lung cancer. The device, called the CivaSheet®, is implanted permanently and uses a special configuration to target cancer cells more precisely. This approach aims to provide effective treatment to the cancerous area while reducing the radiation dose to important nearby structures, such as the heart.
Eligibility Criteria
Inclusion Criteria
- Must have signed an informed consent form.
- Have suspected or confirmed non-small cell lung cancer (NSCLC) located in the upper lobes of either lung.
- Meet specific pre-operative criteria.
- Have a lung nodule that is suspicious for NSCLC.
- The tumor must be 7 cm or smaller in its largest dimension, as seen on a CT scan of the chest and upper abdomen.
- Be in clinical stage I or II of lung cancer.
- Must not be pregnant or nursing.
- Premenopausal women must have a negative pregnancy test.
- Fertile patients must agree to use effective birth control.
- Must be more than 5 years past any previous invasive cancer, except for non-melanoma skin cancer or in-situ cancer.
Exclusion Criteria
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