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

Description

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

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Study Overview

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Study Details

Study overview

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.

The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer

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

Condition
Stage I Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt-Ingram Cancer Center,

Fabien Maldonado, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University/Ingram Cancer Center

Study Record Dates

2026-08-31