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Recruiting NCT06593106

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

No phase Interventional Stage I Lung Cancer Stage II Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryosurgery, Robotic Bronchoscopy, Bronchoscopy with Biopsy, Resection.
Who it may be relevant to
Registry conditions: Stage I Lung Cancer, Stage II Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

PRIMARY OBJECTIVE:

I. To identify the maximum tolerated dose (MTD) for cryodevitalization cycle duration.

OUTLINE: This is a dose-escalation study.

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 radiography (x-ray) on study as well as computed tomography (CT) and tissue sample collection throughout the study.

After completion of study treatment, patients are followed up at 3 and 7 days and are then followed as clinically required per standard of care for 24 months.

Interventions

  • Procedure Cryosurgery
    Undergo cryodevitalization
  • Procedure Robotic Bronchoscopy
    Undergo standard of care robotic bronchoscopy with biopsy
  • Procedure Bronchoscopy with Biopsy
    Undergo standard of care robotic bronchoscopy with biopsy
  • Procedure Resection
    Undergo standard of care surgical resection
  • Procedure Chest Radiography
    Undergo chest x-ray
  • Procedure Computed Tomography
    Undergo Computed Tomography
  • Procedure Biospecimen Collection
    Undergo tissue sample collection
  • Other Electronic Health Record Review
    Ancillary studies

Primary outcome measures

  • Maximum tolerated dose for cryodevitalization cycle duration [Time frame: At time of surgery]
  • Feasibility of bronchoscopically delivered cryodevitalization [Time frame: At time of surgery]
  • Incidence of adverse events [Time frame: Up to 7 days post-cryosurgery]
Secondary outcome measures (2)
  • Pathologic response [Time frame: At time of surgical resection]
  • Incidence of adverse events [Time frame: From day 8 post-cryosurgery to surgical resection]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Vanderbilt University/Ingram Cancer Center — Nashville

Identifiers

NCT: NCT06593106 · VICC-VCTHO24099 · NCI-2024-07299 · P30CA068485

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗