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New treatment option for Stage I Lung Cancer
Official title Cryodevitalization for the Treatment of Early Stage Lung Cancer, CRYSTAL Trial
ClinicalTrials.gov ID: NCT06593106
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a single pulmonary nodule with a size less than or equal to three centimeters (average long and short axis) confirmed as malignant...
- 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...
- Patients deemed to have a surgical resection treatment option based on preoperative staging computed tomographic (CT), postoperative predicted forced...
- Age \> 18 years old
You likely can't join if
- Target nodule is within the International Association for the Study of Lung Cancer (IASLC) "central zone" (including bronchial tree, major vessels...
- 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 \ 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
See the full eligibility criteria
- 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...
- 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...
- Age \> 18 years old
- 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...
- 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 \ 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
- Patients with medical comorbidities deemed high-risk for surgical resection
- Pregnant women
- Inability to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.