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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT06593106
Status
Recruiting
Apply to this trial

Conditions

  • Stage I Lung Cancer
  • Stage II Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 27, 2024
Status verified
Jan 2026
Primary completion
Jul 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    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.

Primary Outcome Measure

Maximum tolerated dose for cryodevitalization cycle duration [ Time Frame: At time of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37203
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Fabien Maldonado, MD (PRINCIPAL_INVESTIGATOR)

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Vanderbilt University/Ingram Cancer Center· Nashville, TN

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