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

Last updated: November 6, 2024
Sponsor: Vanderbilt-Ingram Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Bronchoscopy with Biopsy

Biospecimen Collection

Chest Radiography

Clinical Study ID

NCT06593106
VICC-VCTHO24099
NCI-2024-07299
P30CA068485
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a single pulmonary nodule with a size less than or equal to threecentimeters (average long and short axis) confirmed as malignant intraprocedurally (rapid on-site evaluation with pathology assessment showing lung cancer oroligometastatic disease) without evidence of mediastinal involvement who requirenodule 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 toavoid injury to other visceral organs

  • Patients deemed to have a surgical resection treatment option based on preoperativestaging computed tomographic (CT), postoperative predicted forced expiratory volumein 1 second (FEV1) > 40% and evaluation of medical comorbidities after discussion atmultidisciplinary tumor board

  • Age > 18 years old

Exclusion

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 duringthe 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 systolicpressure] > 50mmHg)

  • Patients who are currently prescribed anticoagulants, clopidogrel, or other plateletaggregation inhibitors

  • Patients with medical comorbidities deemed high-risk for surgical resection

  • Pregnant women

  • Inability to provide informed consent

Study Design

Total Participants: 30
Treatment Group(s): 8
Primary Treatment: Bronchoscopy with Biopsy
Phase:
Study Start date:
October 24, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.