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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment 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 combined with other therapies like chemotherapy. This suggests that CivaSheet, which uses a similar approach, might also be effective for lung cancer. ^{1 2 3 4 5}

How is the CivaSheet treatment for lung cancer different from other treatments?

CivaSheet is a unique brachytherapy (internal radiation therapy) device that uses Pd-103, a radioactive isotope, to deliver targeted radiation directly to the tumor site, potentially reducing exposure to surrounding healthy tissue. Unlike traditional high-dose-rate brachytherapy, which often uses Iridium-192 and requires complex equipment, CivaSheet can be implanted during surgery, offering a more localized and potentially less invasive treatment option. ^{4 5 6 7 8}

Research Team

Abe Wu, MD

Principal Investigator

MSKCC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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]

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]

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]

References

1. United States 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. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Curative irradiation of limited endobronchial carcinomas with high-dose rate brachytherapy. Results of a pilot study. [2019]

3. China 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]. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as sole modality for early-stage endobronchial carcinoma. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

CT-guided interstitial brachytherapy of primary and secondary lung malignancies: results of a prospective phase II trial. [2022]

8. United States 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. [2021]