CivaSheet for Lung Cancer
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: CivaTech Oncology
Disqualifiers: Pregnancy, Recent invasive malignancy, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
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.
12345How 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.
45678Eligibility 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.
+7 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
NYU Langone HealthNew York City, NY
Mission Hospital St JoesphMission Viejo, CA
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
CivaTech OncologyLead Sponsor
References
Image-guided interstitial high-dose-rate brachytherapy for dose escalation in the radiotherapy treatment of locally advanced lung cancer: A single-institute experience. [2020]To evaluate the clinical outcome after CT-guided interstitial high-dose-rate (HDR) brachytherapy for dose escalation in the radiotherapy treatment of inoperable locally advanced non-small-cell lung cancer (NSCLC).
Curative irradiation of limited endobronchial carcinomas with high-dose rate brachytherapy. Results of a pilot study. [2019]Pilot study to assess high-dose rate (HDR) brachytherapy as sole treatment for limited endobronchial non-small cell lung carcinomas.
[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]Brachytherapy offers an innovative method of delivering conformal high-dose radiation to a defining target tumor. The aim of this study is to investigate the value and effect of using radioactivity ¹²⁵I seed permanent implants combined with chemotherapy in the management of stage III or IV lung cancer.
High-dose-rate brachytherapy as sole modality for early-stage endobronchial carcinoma. [2019]To evaluate exclusive high-dose-rate brachytherapy for localized early-stage non-small-cell bronchial carcinoma; to develop new insights in treatment-catheter positioning and tumor-volume assessment by computed tomography (CT) scan.
Brachytherapy in the treatment of thoracic tumors. Lung and esophageal. [2019]Brachytherapy for carcinoma of the lung is most often performed using HDR remote afterloading equipment which delivers the treatment within the tracheal-bronchial tree in an outpatient setting. It provides excellent palliation, rapidly, and can also be selectively used with for curative intent. Permanent implantation using iodine seeds at the time of surgery improves the local control rate for those patients. Esophageal brachytherapy is performed as an intraluminal technique, most often using HDR equipment in an outpatient setting, and is used for palliation as a single modality and as a boost following chemo/radiation for curative patients. In this latter situation, the more aggressive therapy provides significantly better palliation than is possible with single-modality therapy.
High Dose Rate Remote Afterloading Brachytherapy for Lung and Esophageal Cancer. [2019]High dose rate brachytherapy for lung and esophageal cancer is performed by placing a high activity Iridium 192 source into the lumen of the airway of esophagus. Because of the high activity of the source it remains in place for only a matter of minutes, and fractionated treatments are feasible. Before this development, conventional dose rate brachytherapy required hospitalization with attendant patient discomfort, expense, and complicated radiation safety requirements. The development of high activity remote afterloading machines has removed these practical disadvantages and has led to a great interest in the use of this technology for radical treatment and palliation of obstructing malignancies. There are several unresolved issues concerning this modality for both lung and esophageal cancer. For both diseases, optimal dose and fractionation schemes are not well defined but the palliative benefits for recurrent lung cancer have been clearly shown. The use of a brachytherapy boost following radical external beam radiation therapy of lung cancer is not proven to be advantageous. For esophageal cancer, the value of brachytherapy for palliation is not established. However, there are preliminary data to suggest that it can improve outcome when used routinely after radical treatment with external beam radiation therapy.
CT-guided interstitial brachytherapy of primary and secondary lung malignancies: results of a prospective phase II trial. [2022]CT-guided interstitial brachytherapy of primary lung malignancies and pulmonary metastases represents a novel interventional technique, combining conventional high-dose-rate (HDR) iridium-192 ((192)Ir) brachytherapy with modern CT guidance for applicator positioning and computer-aided 3-D radiation treatment planning. The purpose of this study was to assess safety and efficacy of this technique.
A novel ytterbium-169 brachytherapy source and delivery system for use in conjunction with minimally invasive wedge resection of early-stage lung cancer. [2021]To describe a novel source-delivery system for intraoperative brachytherapy in patients with early-stage lung cancer that is readily adaptable to a video-assisted thoracoscopic surgery approach and can be precisely delivered to achieve optimal dose distribution.