CivaSheet for Lung Cancer

Recruiting at 3 trial locations

Overseen By Kristy Perez, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CivaTech Oncology

Disqualifiers: Pregnancy, Recent invasive malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CivaSheet, for lung cancer patients. CivaSheet is a brachytherapy device that delivers radiation directly to the cancer site while protecting nearby healthy tissues, such as the heart. Researchers aim to determine if this approach safely benefits people with non-small cell lung cancer (NSCLC) in the upper lobes of their lungs. This trial may suit those with a lung mass 7 cm or smaller, at an early stage of NSCLC, and not currently pregnant or nursing. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the CivaSheet device is safe for lung cancer patients?

Research shows that the CivaSheet safely targets cancer while protecting healthy tissues by emitting radiation on only one side. This design allows placement near sensitive areas, such as the heart, without causing harm.

The FDA has already approved the CivaSheet for other uses, indicating its relative safety. However, studies involving radiation require careful attention, particularly near vital organs. Current studies are examining how well people tolerate the CivaSheet. While more research is needed to fully understand all possible side effects, the device aims to treat tumors while minimizing harm to healthy tissues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike standard lung cancer treatments, which often include external beam radiation or chemotherapy, CivaSheet is unique because it uses a directional brachytherapy approach. This treatment features a planar radiation source with gold shielding, allowing it to deliver high doses of radiation directly to the tumor while protecting nearby healthy tissue. Researchers are excited about CivaSheet because it offers precise targeting, which could minimize side effects and improve patient outcomes compared to traditional therapies.

What evidence suggests that this brachytherapy device is effective for lung cancer?

Research has shown that the CivaSheet, which participants in this trial will receive, is a promising tool for treating lung cancer. This device is unique because it delivers radiation in only one direction, targeting the cancer while protecting nearby healthy tissue. Studies on similar treatments have demonstrated their effectiveness in focusing on lung tumors and improving cancer control. Early results suggest that CivaSheet could be a practical way to apply radiation directly to cancer-affected areas. This approach may reduce the radiation dose to critical areas like the heart while still effectively treating the cancer. ^{1 3 6 7 8}

Who Is on the Research Team?

Abe Wu, MD

Principal Investigator

MSKCC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am preparing for surgery.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CivaSheet directional Pd-103 Brachytherapy for lung cancer treatment

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for local control rate and recurrence for up to 1 year

1 year

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• CivaSheet

Trial Overview

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.

How Is the Trial Designed?

Group I: CivaSheet Directional LDR Brachytherapy Experimental Treatment 1 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.

CivaSheet is already approved in United States for the following indications:

Approved in United States as CivaSheet for:

• Lung cancer
• Pancreatic cancer
• Soft tissue sarcomas
• Colorectal cancer
• Gynecologic cancer
• Head and neck cancer

Who Is Running the Clinical Trial?

CivaTech Oncology

Lead Sponsor

Trials

7

Recruited

310+

Published Research Related to This Trial

High-dose rate (HDR) brachytherapy for lung cancer is effective for both palliative care and curative treatment, allowing for rapid symptom relief in an outpatient setting.

Permanent implantation of iodine seeds during surgery enhances local control of lung cancer, and esophageal brachytherapy, especially when combined with chemotherapy or radiation, significantly improves palliative outcomes compared to single-modality treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brachytherapy in the treatment of thoracic tumors. Lung and esophageal. Speiser, BL.[2019]

In a study involving 30 patients with lung malignancies, CT-guided interstitial brachytherapy demonstrated a high local tumor control rate of 91% at 12 months, indicating its efficacy in treating both primary and secondary lung cancers.

The procedure was found to be safe, with only minor adverse effects reported, including nausea and a single case of major pneumothorax, and no significant changes in lung function were observed post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-guided interstitial brachytherapy of primary and secondary lung malignancies: results of a prospective phase II trial. Peters, N., Wieners, G., Pech, M., et al.[2022]

In a pilot study involving 19 patients with limited endobronchial non-small cell lung cancer, high-dose rate (HDR) brachytherapy demonstrated a high local control rate, with 83% of evaluable patients showing tumor control two months post-treatment and 75% at one year.

Despite its effectiveness, HDR brachytherapy was associated with significant late toxicity, including severe necrosis of the bronchial wall in some patients, indicating that this treatment should be reserved for carefully selected individuals with no other curative options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curative irradiation of limited endobronchial carcinomas with high-dose rate brachytherapy. Results of a pilot study. Pérol, M., Caliandro, R., Pommier, P., et al.[2019]

In a study of 42 patients with stage III and IV lung cancer, the use of ¹²⁵I seed permanent implants combined with chemotherapy resulted in a high treatment response rate of 85.7%, with 26.2% achieving complete response and 59.5% showing partial response.

The procedure demonstrated a satisfaction rate of 83.3% for seed distribution and was associated with relatively low complications, including mild hemothorax and pneumothorax, while serious side effects like leucopenia and radiation pneumonia were not observed, indicating it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A preliminary result of radioactivity ¹²⁵I seed implants with micropuncture technique combined with chemotherapy in the treatment of stage III and IV lung cancer]. Fu, G., Lei, G., Bai, X., et al.[2011]

Exclusive high-dose-rate brachytherapy for localized early-stage non-small-cell bronchial carcinoma resulted in an 85% local control rate and a 78% survival rate over a median follow-up of 2 years, indicating its efficacy as a treatment option for medically inoperable patients.

The treatment was associated with minimal toxicity, with only one case of pneumothorax reported, demonstrating a favorable safety profile when careful tumor volume assessment and individualized catheter positioning were employed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as sole modality for early-stage endobronchial carcinoma. Marsiglia, H., Baldeyrou, P., Lartigau, E., et al.[2019]

High dose rate brachytherapy using Iridium 192 for lung and esophageal cancer offers a quick treatment option that reduces patient discomfort and hospital stays compared to conventional methods.

While the palliative benefits of brachytherapy for recurrent lung cancer are evident, its effectiveness for esophageal cancer remains uncertain, although preliminary data suggest it may enhance outcomes when used after external beam radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Dose Rate Remote Afterloading Brachytherapy for Lung and Esophageal Cancer. Armstrong, JG.[2019]

CT-guided interstitial high-dose-rate (HDR) brachytherapy for inoperable locally advanced non-small-cell lung cancer (NSCLC) showed promising outcomes, with a median overall survival of 12.9 months and local control of 24.9 months after a median follow-up of 12.5 months.

The treatment was found to be safe, with only minor adverse events reported, including one case of a persistent cough and a minor hemopneumothorax, indicating that HDR brachytherapy could be a viable option for dose escalation in NSCLC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided interstitial high-dose-rate brachytherapy for dose escalation in the radiotherapy treatment of locally advanced lung cancer: A single-institute experience. Chatzikonstantinou, G., Zamboglou, N., Baltas, D., et al.[2020]

A novel brachytherapy source-delivery system using radioactive ytterbium-169 has been developed for early-stage lung cancer, allowing for precise placement during video-assisted thoracoscopic surgery.

The system ensures minimal perturbation of dose distribution (only 4-5% deviation) compared to traditional iodine-125 sources, while also reducing radiation exposure to clinicians and maintaining the seeds' position throughout treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel ytterbium-169 brachytherapy source and delivery system for use in conjunction with minimally invasive wedge resection of early-stage lung cancer. Leonard, KL., DiPetrillo, TA., Munro, JJ., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03290534

NCT03290534 | Feasibility Study to Treat Lung Cancer ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5856973/

The CivaSheet: The new frontier of intraoperative radiation ...

The CivaSheet is a new device that may offer an acceptable alternative because its unidirectional nature facilitates highly localized radiation delivery.

3.

withpower.com

withpower.com/trial/phase-3-lung-neoplasms-2-2019-f57bb

CivaSheet for Lung Cancer

Research on similar treatments, like high-dose-rate brachytherapy, shows that it can effectively target lung tumors and improve local control, especially when ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12167782/

Prospective Evaluation of a Novel Unidirectional ...

This is the first published clinical trial of a novel unidirectional brachytherapy device. CivaSheet proved to be a feasible technique to ...

5.

clinicaltrials.med.nyu.edu

clinicaltrials.med.nyu.edu/clinicaltrial/777/civatech-oncologyfeasibility-study-treat/

CivaTech Oncology:Feasibility study to treat lung cancer with ...

This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/9566125

Project Details - NIH RePORTER

The CivaSheet decreases the time between surgery and radiation therapy, which is a benefit to the patient. Additionally, the CivaSheet can shield healthy ...

7.

advancesradonc.com

advancesradonc.com/article/S2452-1094(17)30200-2/fulltext

The new frontier of intraoperative radiation therapy or a ...

The CivaSheet is a new device that may offer an acceptable alternative because its unidirectional nature facilitates highly localized radiation delivery while ...

8.

civatechoncology.com

civatechoncology.com/wp-content/uploads/2019/04/VCU-CivaSheet-sarcoma-trunk.pdf

The CivaSheet: The new frontier of intraoperative radiation ...

When defining the balance between tumor control and toxicities, considerable caution must be exercised near organs with serial functional subunits, ...