Stage I Lung CancerNCT06593106
Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
A study testing Cryosurgery, Robotic Bronchoscopy and Bronchoscopy with Biopsy in people with Stage I Lung Cancer and Stage II Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Lung Cancer, Stage II Lung Cancer
- What is being tested?
- Cryosurgery, Robotic Bronchoscopy and Bronchoscopy with Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients with known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg)
- Patients who are currently prescribed anticoagulants, clopidogrel, or other platelet aggregation inhibitors
Show all 9Show fewer
- Patients with medical comorbidities deemed high-risk for surgical resection
- Pregnant women
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
About this study
Official title: The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Stage I Lung Cancer, Stage II Lung Cancer
- Being tested
- Cryosurgery, Robotic Bronchoscopy, Bronchoscopy with Biopsy, Resection, Chest Radiography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryosurgeryProcedure or surgery
Undergo cryodevitalization
Robotic BronchoscopyProcedure or surgery
Undergo standard of care robotic bronchoscopy with biopsy
Bronchoscopy with BiopsyProcedure or surgery
Undergo standard of care robotic bronchoscopy with biopsy
ResectionProcedure or surgery
Undergo standard of care surgical resection
Chest RadiographyProcedure or surgery
Undergo chest x-ray
Computed TomographyProcedure or surgery
Undergo Computed Tomography
Biospecimen CollectionProcedure or surgery
Undergo tissue sample collection
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cryosurgery; Procedure: Robotic Bronchoscopy; Procedure: Bronchoscopy with Biopsy; Procedure: Resection; Procedure: Chest Radiography; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery
Feasibility of bronchoscopically delivered cryodevitalization
Proportion of procedures that can be safely completed with full dose delivered
Measured: 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.
Measured: Up to 7 days post-cryosurgery
Secondary outcomes (2)
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.
Measured: At time of surgical resection
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.
Measured: From day 8 post-cryosurgery to surgical resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Swim Across America
- Responsible party
- Principal investigator, Fabien Maldonado, Vanderbilt-Ingram Cancer Center
- Investigators
- Fabien Maldonado, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593106
- Sponsor's protocol ID
- VICC-VCTHO24099
- Other IDs
- NCI-2024-07299, P30CA068485
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CRYSTAL Study: Cryodevitalization Study for the Treatment of Early-Stage Lung Cancer
- ClinicalTrials.gov ID
- NCT06593106
- Acronym / sponsor ID
- VICC-VCTHO24099
- Conditions
- Stage I Lung Cancer, Stage II Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Swim Across America
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Cryosurgery, Procedure: Robotic Bronchoscopy, Procedure: Bronchoscopy with Biopsy, Procedure: Resection, Procedure: Chest Radiography, Procedure: Computed Tomography, Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Patients with known pulmonary hypertension (PASP [pulmonary artery systolic pressure] > 50mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryosurgeryUndergo cryodevitalization | Procedure or surgery | Treatment |
| Robotic BronchoscopyUndergo standard of care robotic bronchoscopy with biopsy | Procedure or surgery | Treatment |
| Bronchoscopy with BiopsyUndergo standard of care robotic bronchoscopy with biopsy | Procedure or surgery | Treatment |
| ResectionUndergo standard of care surgical resection | Procedure or surgery | Treatment |
| Chest RadiographyUndergo chest x-ray | Procedure or surgery | Treatment |
| Computed TomographyUndergo Computed Tomography | Procedure or surgery | Treatment |
| Biospecimen CollectionUndergo tissue sample collection | Procedure or surgery | Treatment |
| Electronic Health Record ReviewAncillary studies | Other | Treatment |
Primary outcome
Maximum tolerated dose for cryodevitalization cycle duration
Time frame: At time of surgery
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.
Feasibility of bronchoscopically delivered cryodevitalization
Time frame: At time of surgery
Proportion of procedures that can be safely completed with full dose delivered
Incidence of adverse events
Time frame: Up to 7 days post-cryosurgery
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.
2 secondary outcomes
Pathologic response
Time frame: At time of surgical resection
Incidence of adverse events
Time frame: From day 8 post-cryosurgery to surgical resection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Maldonado, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryosurgery, Robotic Bronchoscopy and Bronchoscopy with Biopsy in people with Stage I Lung Cancer and Stage II Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose for cryodevitalization cycle duration (time frame: At time of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.