# Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer

> **NIH NIH R44** · CIVATECH ONCOLOGY, INC. · 2020 · $595

## Abstract

CivaTech Oncology’s mission is to provide improved radiation therapy directly to localized
tumors. The Company has developed a novel, polymer-encapsulated, membrane-like radiation source
that emits radiation on only one side of the device – the CivaSheet. This directional source is compatible
with open and minimally invasive surgical techniques and has FDA clearance to be used as primary or
combined cancer therapy. The CivaSheet is a partially bio-absorbable implant that can be applied at the
time of the initial surgery. The CivaSheet decreases the time between surgery and radiation therapy,
which is a benefit to the patient. Additionally, the CivaSheet can shield healthy tissues while irradiating
the diseased tissue or tumor margin. This shielding enables the CivaSheet to be implanted close to
radiosensitive structures without overdosing them – a potential advantage for cancers in the thorax.
 In Phase I, CivaTech Oncology will confirm the CivaSheet does not move after implantation and
that excellent dosimetry can be achieved. The CivaSheet will be implanted during lung lobe
segmentation or wedge resection – a standard of care procedure for lung cancer patients who cannot
tolerate full lobectomy. The CivaSheet will benefit these patients by delivering radiation therapy at the
time of initial surgery to minimize delay in the treatment. For lung cancer patients complete lobectomy
is preferred for patients who can tolerate it. For those who cannot, radiation to the surgical margin is a
potential benefit. In Phase I, the safety of CivaSheet and general recommendations for its use in this
patient population will be assessed. Changes to the surgical implant technique will be assessed as well.
 The Phase II will consist of two concurrent clinical trials exploring the use of the CivaSheet as
boost radiation therapy in lung cancer patients. The rate of local recurrence in patients implanted with
CivaSheet will be compared to the current rate of 20%. Additionally, the quality of life, pain, and
mortality in each patient will be monitored. CivaSheet will reduce the radiation delivered to adjacent
mediastinum and therefore should result in fewer side effects. Additionally, it will provide a conformal
dose, reduce the risk for infection, and possibly reduce treatment related side effects.
 CivaSheet is a truly unique brachytherapy device that has the potential to become the first line
of defense for localized cancer. CivaTech Oncology is committed to making the CivaSheet available to
cancer patients in multiple indications.

## Key facts

- **NIH application ID:** 10250609
- **Project number:** 3R44CA217587-03S1
- **Recipient organization:** CIVATECH ONCOLOGY, INC.
- **Principal Investigator:** Kristy Perez
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $595
- **Award type:** 3
- **Project period:** 2017-09-13 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10250609

## Citation

> US National Institutes of Health, RePORTER application 10250609, Clinical evaluation of the novel, uni-directional, Pd-103 CivaSheet for Lung Cancer (3R44CA217587-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10250609. Licensed CC0.

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