RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether CivaSheet, a device left in the body to give low-dose radiation, may help treat lung cancer. It is for people with suspected or confirmed non-small cell lung cancer in the upper part of either lung. The goal is to give radiation to cancer tissue near the edge of surgery while limiting radiation to areas such as the heart wall.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must sign a form agreeing to take part in the study.
  • You must have suspected or confirmed non-small cell lung cancer in the upper part of either lung.
  • Before surgery, you must have a lung spot that may be non-small cell lung cancer.
  • The lung mass must be 7 centimeters or smaller at its widest point on a CT scan of the chest and upper belly.
  • The cancer must be stage I or II, based on tests before surgery.
  • You must not be pregnant or breastfeeding. Women who have not gone through menopause must have a negative pregnancy test.
  • If you can have children, you must use effective birth control.
  • Any past cancer that grew into nearby tissue must have been more than 5 years ago. This rule does not apply to non-melanoma skin cancer or cancer that stayed where it started.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official 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: \-

    Study sites (1)

    NY