Cryosurgery for Early Stage Lung Cancer

Overseen By Vanderbilt-Ingram Services for Timely Access

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt-Ingram Cancer Center

Must not be taking: Anticoagulants, Clopidogrel

Disqualifiers: Pulmonary hypertension, Coagulopathy, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special freezing technique called cryodevitalization (also known as cryosurgery, cryoablation, or cryotherapy) to treat early-stage lung cancer. The goal is to assess the safety and effectiveness of freezing and killing cancer cells during a regular lung examination. Suitable participants have a single cancerous lung nodule smaller than three centimeters, located in the outer part of the lung, and are planning to undergo surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in lung cancer treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants, clopidogrel, or other platelet aggregation inhibitors if you are currently prescribed them.

What prior data suggests that cryodevitalization is safe for treating early stage lung cancer?

Studies have shown that cryodevitalization, a type of cryosurgery, may be safe and manageable for patients with early-stage lung cancer. This treatment uses a special tool to freeze and destroy cancer cells, and research indicates it usually causes only minor side effects that often resolve on their own.

In some studies, patients who underwent similar cryosurgery treatments had good survival rates, with 80% living at least 12 months after treatment. This suggests that cryodevitalization could be a promising option for those with early-stage lung cancer. However, every treatment has risks, so discussing these with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryodevitalization is unique because it uses a controlled freeze-thaw cycle to target and destroy cancer cells in early-stage lung cancer. Unlike traditional treatments like surgery or radiation, which can affect surrounding healthy tissue, this method aims to minimize damage by precisely targeting only the tumor. Researchers are excited about this approach because it combines cutting-edge cryosurgery with robotic bronchoscopy, potentially offering a less invasive and more targeted option for patients. This technique could lead to quicker recovery times and fewer side effects compared to conventional treatments.

What evidence suggests that cryodevitalization might be an effective treatment for early stage lung cancer?

Research has shown that cryoablation, also known as cryodevitalization, effectively treats early-stage non-small cell lung cancer (NSCLC). This method is particularly beneficial for patients unable to undergo traditional surgery. Studies indicate that this cold treatment is safe and typically results in fewer complications compared to methods like radiofrequency ablation (RFA). In some studies, about 81.8% of patients survived one year after cryoablation. This finding suggests that freezing and killing tumor cells could be a promising treatment for early-stage lung cancer. Participants in this trial will receive cryodevitalization as part of their treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Fabien Maldonado, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with early stage (stage I or II) lung cancer. Participants should be suitable for cryosurgery and diagnostic procedures like robotic bronchoscopy, but specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am older than 18 years.

I have a small lung cancer nodule, confirmed during a procedure, with no spread to the middle chest area.

My doctors believe surgery is an option for my cancer based on my CT scans and lung function tests.

Exclusion Criteria

Patients with an expected survival less than 6 months

Pregnant women

My lung nodule is centrally located or very close to the lung lining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 3 freeze-thaw cycles of cryodevitalization during standard of care robotic bronchoscopy with biopsy, followed by surgical resection, chest x-ray, CT, and tissue sample collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up at 3 and 7 days, and then as clinically required for 24 months

24 months

Multiple visits as clinically required

What Are the Treatments Tested in This Trial?

Interventions

• Cryodevitalization

Trial Overview The CRYSTAL Trial is testing the timing and side effects of cryodevitalization—a procedure that freezes tumor cells—during standard diagnostic robotic bronchoscopy in patients with early stage lung cancer.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 8 Interventions

Patients undergo 3 freeze-thaw cycles of cryodevitalization over 30 seconds or 3, 5, or 7 minutes each during standard of care robotic bronchoscopy with biopsy on study. Patients then undergo standard of care surgical resection on study. Patients also undergo a chest x-ray on study as well as CT and tissue sample collection throughout the study.

Cryodevitalization is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Cryotherapy for:

• Metastatic lung cancer
• Advanced lung cancer
• Symptomatic relief

Approved in United States as Cryotherapy for:

• Early-stage lung cancer
• Metastatic lung cancer
• Symptomatic relief

Approved in Canada as Cryotherapy for:

• Advanced lung cancer
• Symptomatic relief

Approved in Japan as Cryotherapy for:

• Metastatic lung cancer
• Symptomatic relief

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Swim Across America

Collaborator

Trials

8

Recruited

290+

Swim Across America

Collaborator

Trials

11

Recruited

410+

Published Research Related to This Trial

Cryosurgery is a viable treatment option for patients with advanced non-small cell lung cancer (NSCLC) who are not candidates for traditional surgery, with a study of 625 patients showing 1-, 2-, and 3-year survival rates of 64%, 45%, and 32%, respectively.

While cryosurgery can lead to mild and transient adverse effects like haemoptysis and pneumothorax, it also appears to enhance the immune response against tumors, suggesting potential benefits in immunotherapy when combined with cryotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryosurgery for lung cancer. Niu, L., Xu, K., Mu, F.[2022]

Cryoablation is a feasible and minimally invasive treatment for pulmonary metastases in patients who cannot undergo surgery, with a mean hospital stay of just 2.6 days.

The procedure showed satisfactory local control of tumors, with a 1-year survival rate of 89.4%, although there were some complications such as pneumothorax and hemoptysis in a portion of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. Kawamura, M., Izumi, Y., Tsukada, N., et al.[2022]

Percutaneous cryoablation for stage I non-small cell lung cancer in medically inoperable patients showed promising midterm results, with a mean overall survival of 62 months and 2- and 3-year survival rates of 88%.

The procedure had a low local tumor progression rate (3%) and did not significantly affect pulmonary function, indicating that cryoablation may be a safe and effective treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation for the treatment of medically inoperable stage I non-small cell lung cancer. Yamauchi, Y., Izumi, Y., Hashimoto, K., et al.[2022]

This study aims to systematically review the effectiveness and safety of cryoablation for advanced non-small cell lung cancer (NSCLC) by analyzing data from various databases and trial registries, ensuring a comprehensive evaluation of existing research.

The primary outcomes of interest will include the objective response rate and overall survival, while secondary outcomes will assess adverse effects and quality of life, highlighting the potential benefits and risks of cryoablation as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation for advanced non-small cell lung cancer: a protocol for a systematic review. Duan, H., Zheng, SY., Luo, C., et al.[2021]

Percutaneous cryoablation is a safe and effective method for treating lung tumors, offering high local control rates and manageable complications, making it a suitable option for various stages of lung cancer.

The technique not only provides radical cures but also palliative care, and it is increasingly being used for treating pure ground-glass nodules (GGNs), highlighting its versatility in lung cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous imaging-guided cryoablation for lung cancer. Zhang, YS., Niu, LZ., Zhan, K., et al.[2020]

Cryoablation for lung tumors was evaluated in 117 patients across 193 sessions, showing it can be performed with acceptable complication rates, including pneumothorax (61.7%) and pleural effusion (70.5%).

The study identified significant predictors for complications, such as a greater number of cryoprobes used, which increased the risk of pneumothorax and hemoptysis, highlighting the importance of technique in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of lung tumors: feasibility and safety. Inoue, M., Nakatsuka, S., Yashiro, H., et al.[2022]

In a study of 644 lung cancer patients, percutaneous cryoablation was found to be a simple and effective treatment method, demonstrating relative safety with mostly minor complications.

While serious complications like cardiac arrest and hemopneumothorax can occur, they are manageable with preventative measures, highlighting the importance of monitoring during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications of cryoablation in 644 lung cancer patients and its treatment]. Niu, L., Wang, J., Zhou, L., et al.[2023]

Percutaneous cryoablation for primary lung malignancies in patients aged 80 and older shows a high 3-year overall survival rate of 94% and a 100% local recurrence-free survival, indicating its effectiveness for this age group.

While there is a 37% risk of pneumothorax during the procedure, most patients (63%) can be discharged on the same day, with an average length of stay of about 22.6 hours, demonstrating the procedure's safety and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Cryoablation Outcomes in Octogenarians and Nonagenarians with Primary Lung Cancer. Mabud, TS., Swilling, D., Guichet, P., et al.[2023]

This study aims to evaluate the safety of cryoablation in 10 patients with painful bone and soft tissue tumors, focusing on the prevalence of severe adverse events within 4 weeks post-treatment.

The effectiveness of cryoablation will also be assessed 4 weeks after the procedure, providing insights into its potential as a pain management option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502). Iguchi, T., Sakurai, J., Hiraki, T., et al.[2017]

In a study of 45 patients with early-stage non-small cell lung cancer (NSCLC) treated with cryoablation, the 5-year overall survival rate was 67.8%, indicating that this treatment can be effective for long-term survival.

Cryoablation showed a low major complication rate of 6.4%, suggesting it is a safe option for patients who cannot undergo traditional surgery, with no deaths occurring within the first 30 days post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year survival after cryoablation of stage I non-small cell lung cancer in medically inoperable patients. Moore, W., Talati, R., Bhattacharji, P., et al.[2022]

Cryoablation significantly reduced serum CEA levels in patients with adenocarcinoma but not in those with squamous carcinoma, indicating a differential response based on tumor type.

Patients with adenocarcinoma who underwent comprehensive cryoablation had longer overall survival compared to those receiving palliative treatment, and normal pre-treatment CEA levels were associated with better survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinoembryonic antigen as prognostic factor for metastatic non-small cell lung cancer by percutaneous cryosurgery. Li, H., Tang, K., Niu, L., et al.[2014]

Cryoablation for malignant lung tumors demonstrated a high overall survival rate of 96% at 1 year and 88% at both 2 and 3 years, indicating its effectiveness as a treatment option.

While there were some complications such as pneumothorax and pulmonary hemorrhage, no life-threatening events or procedural-related mortality occurred, suggesting that cryoablation is a safe procedure for patients with inoperable lung tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation for inoperable malignant lung tumors: midterm results. Chou, HP., Chen, CK., Shen, SH., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3426750/

Cryosurgery for lung cancer - PMC - PubMed Central - NIH The results showed that cryotherapy was safe with less complications compared with RFA. Since 2000 when Wu in Shanghai performed the first CT-guided ...

2. withpower.com withpower.com/trial/phase-stage-ii-lung-cancer-10-2024-5457b

Cryosurgery for Early Stage Lung Cancer Research shows that cryoablation, a type of cryosurgery, has been effective in treating early-stage non-small cell lung cancer (NSCLC), especially in patients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1930043325004248

Cryoablation as a treatment option for medically inoperable ... The aim of this presentation is to highlight the promising results of cryoablation as a thermal ablation technique for patients with stage IA lung cancer.

4. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.950921/full

Cryoablation and immune synergistic effect for lung cancer The 1-year survival rate was 81.8% and the progression-free rate was 27.8%. Das, S. K. et al. (38) reported data from a study of cryoablation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01957787

Study of Cryoablation for Metastatic Lung Tumors The purpose of this study is to evaluate the safety and efficacy of cryoablation therapy used to treat tumors in participants with pulmonary metastatic disease.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500223007699

Outcomes following cryoablation of stage IA non-small cell ... Prospective and retrospective studies have demonstrated that percutaneous cryoablation of lung tumors is safe with a limited number of minor and mostly self- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01325753?term=AREA%5BBasicSearch%5D(small%20cell%20lung%20ca)&rank=9

Cryotherapy in Treating Patients With Lung Cancer That ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

8. jvir.org jvir.org/article/S1051-0443(25)00724-9/fulltext

Safety and Effectiveness of Non-Small Cell Lung Cancer ... OS was 80% at 12-months and 57% at 24-months without difference between cryoablation and microwave ablation. Abstract. Purpose. To report ...