Health TrialsbyHealthPanel

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

ConditionsStage I Lung CancerStage II Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryosurgery

    Procedure/Surgery

    Undergo cryodevitalization

  • Robotic Bronchoscopy

    Procedure/Surgery

    Undergo standard of care robotic bronchoscopy with biopsy

  • Bronchoscopy with Biopsy

    Procedure/Surgery

    Undergo standard of care robotic bronchoscopy with biopsy

  • Resection

    Procedure/Surgery

    Undergo standard of care surgical resection

  • Chest Radiography

    Procedure/Surgery

    Undergo chest x-ray

  • Computed Tomography

    Procedure/Surgery

    Undergo Computed Tomography

  • Biospecimen Collection

    Procedure/Surgery

    Undergo tissue sample collection

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Maximum tolerated dose for cryodevitalization cycle duration

Will implement a modified Toxicity Probability Interval design. Each dose will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

Time frame
At time of surgery
2

Feasibility of bronchoscopically delivered cryodevitalization

Proportion of procedures that can be safely completed with full dose delivered

Time frame
At time of surgery
3

Incidence of adverse events

Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

Time frame
Up to 7 days post-cryosurgery

Secondary outcomes

1

Pathologic response

Pathologic response will be assessed comparing the confirmed devitalization zone determined by intraprocedural cone-beam computed tomography imaging (percent tumor treated by cryodevitalization) and remaining tumor viability by histopathologic examination of resected specimens.

Time frame
At time of surgical resection
2

Incidence of adverse events

Will be modeled using a Beta-Binomial model with the prior distribution, Beta (1,1). For each dose level, a 95% credible interval for the toxicity probability will be computed.

Time frame
From day 8 post-cryosurgery to surgical resection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Swim Across America

Collaborator

Source ClinicalTrials.gov
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