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

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.

Conditions

• Stage I Lung Cancer
• Stage II Lung Cancer

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Swim Across America

  collaborator OTHER

• Vanderbilt-Ingram Cancer Center

  lead OTHER

Principal Investigators

• Fabien Maldonado, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-27

Primary Completion

2026-07-30

Completion

2026-08-31

Countries

• United States

Study Locations