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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-07299 | Registry Identifier | NCI, Clinical Trials Reporting Program | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Swim Across America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryosurgery | Procedure | Undergo cryodevitalization |
| |
| Robotic Bronchoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of surgery |
| Feasibility of bronchoscopically delivered cryodevitalization | Proportion of procedures that can be safely completed with full dose delivered | At time of surgery |
| 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. | Up to 7 days post-cryosurgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of surgical resection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt-Ingram Services for Timely Access | Contact | 800-811-8480 | cip@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Fabien Maldonado, MD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2024 | Nov 6, 2024 |
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| 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 |
|
| 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. |
| From day 8 post-cryosurgery to surgical resection |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| D001999 | Bronchoscopy |
| D001706 | Biopsy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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