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Brachytherapy

CivaSheet for Lung Cancer

Phase 2

Recruiting

Led By Abe Wu, MD

Research Sponsored by CivaTech Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mass ≤ 7 cm in maximum diameter by CT scan of the chest and upper abdomen

More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cancer treatment device to see if it is safe and effective. The device uses active components of standard devices in a new way, which may reduce the amount of radiation to healthy tissue while giving a therapeutic dose to diseased tissue.

Who is the study for?

This trial is for adults with suspected or confirmed non-small cell lung cancer (NSCLC) in the upper lobes of their lungs. The tumor must be no larger than 7 cm, and patients should be in early stages (I or II) of cancer. They shouldn't be pregnant or nursing, and if they can have children, they need to use birth control. Those with a history of invasive cancers other than skin cancer within the last five years are excluded.

What is being tested?

The study is testing CivaSheet, an implantable low-dose radiation therapy device designed to treat lung cancer while minimizing damage to healthy tissues like the heart wall. It's being evaluated for its effectiveness at delivering therapeutic doses directly to areas needing treatment after surgery.

What are the potential side effects?

While specific side effects aren't listed here, brachytherapy devices like CivaSheet may cause localized pain, swelling, bruising at the implant site; there could also be risks associated with radiation exposure such as fatigue and skin changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is 7 cm or smaller, as shown by a CT scan.

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I haven't had cancer, except for non-melanoma skin or in-situ cancer, in over 5 years.

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I am not pregnant.

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My cancer is in the early stages (stage I or II).

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My lung cancer is in the upper part of my left or right lung.

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I have a lung spot that may be non-small cell lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Local Control Rate at 1 year

Secondary study objectives

Freedom from regional or distant recurrence

Time to recurrence

Toxicity graded on CTCAE 4.0 Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CivaSheet Directional LDR BrachytherapyExperimental Treatment1 Intervention

FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CivaSheet

2016

Completed Phase 1

~20

0 / 6Eligibility criteria met