Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial

NCT06593106 | Recruiting DMC

• 3 other identifiers: VICC-VCTHO24099NCI-2024-07299P30CA068485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies side effects and best treatment time of cryodevitalization in treating patients with early stage (stage I or stage II) lung cancer. Cryodevitalization is a type of cryosurgery that uses a flexible probe (cryoprobe) to kill tumor cells by freezing them. It is delivered at the time of standard diagnostic robotic bronchoscopy. Using cryodevitalization may be safe, tolerable and/or effective in treating patients with early stage lung cancer.

Conditions

Stage I Lung Cancer; Stage II Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose for cryodevitalization cycle duration

  Will implement a modified Toxicity Probability Interval design. Each dose will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

  At time of surgery

• Feasibility of bronchoscopically delivered cryodevitalization

  Proportion of procedures that can be safely completed with full dose delivered

  At time of surgery

• Incidence of adverse events

  Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

  Up to 7 days post-cryosurgery

Secondary Outcomes (2)

• Pathologic response

  At time of surgical resection

• Incidence of adverse events

  From day 8 post-cryosurgery to surgical resection

Study Arms (1)

Treatment

EXPERIMENTAL

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.

Procedure: Cryosurgery; Procedure: Robotic Bronchoscopy; Procedure: Bronchoscopy with Biopsy; Procedure: Resection; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Interventions

Robotic Bronchoscopy PROCEDURE

Undergo standard of care robotic bronchoscopy with biopsy

Treatment

Bronchoscopy with Biopsy PROCEDURE

Undergo standard of care robotic bronchoscopy with biopsy

Treatment

Resection PROCEDURE

Undergo standard of care surgical resection

Treatment

Chest Radiography PROCEDURE

Undergo chest x-ray

Treatment

Computed Tomography PROCEDURE

Undergo Computed Tomography

Treatment

Biospecimen Collection PROCEDURE

Undergo tissue sample collection

Treatment

Electronic Health Record Review OTHER

Ancillary studies

Treatment

Cryosurgery PROCEDURE

Undergo cryodevitalization

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer or oligometastatic disease) without evidence of mediastinal involvement who require nodule biopsy prior to proceeding with surgical resection
• Nodules must be located in the outer 2/3 of the periphery of the lung, greater than 10 mm from the pleura and from large blood vessels or mediastinal structures to avoid injury to other visceral organs
• Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced expiratory volume in 1 second (FEV1) \> 40% and evaluation of medical comorbidities after discussion at multidisciplinary tumor board
• Age \> 18 years old

You may not qualify if:

• Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels, heart, esophagus, spinal cord and phrenic \& laryngeal nerves), or are \< 10 mm from the pleura
• Patients with an expected survival less than 6 months
• Patients with endobronchial lesions, concerning for malignancy, visualized during the initial bronchoscopic evaluation of the airways
• Patients with medically uncorrectable coagulopathy: abnormal platelet count \< 100 × 10\^9/L or an international normalized ratio \> 1.5
• Patients with known pulmonary hypertension (PASP \[pulmonary artery systolic pressure\] \> 50mmHg)
• Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
• Patients with medical comorbidities deemed high-risk for surgical resection
• Pregnant women
• Inability to provide informed consent

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Swim Across America: collaborator

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cryosurgery; Bronchoscopy; Biopsy; X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Thoracic Surgery

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)