RECRUITING

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

Conditions

Stage I Lung Cancer Stage II Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-24

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06593106

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480

cip@vumc.org

Principal Investigator

Fabien Maldonado, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University/Ingram Cancer Center

Study Locations (Sites)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203

United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-10-24

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Stage I Lung Cancer
Stage II Lung Cancer