Clinical trial · Interventional
Cryotherapy in Treating Patients With Primary Lung Cancer or Lung Metastases That Cannot Be Removed By Surgery
Percutaneous Thoracic Cryotherapy (PTC) for Inoperable Primary Lung Cancer and Metastatic Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Cryotherapy kills tumor cells by freezing them. This may be an effective treatment for primary lung cancer or lung metastases that cannot be removed by surgery. PURPOSE: This clinical trial is studying how well cryotherapy works in treating patients with primary lung cancer or lung metastases that cannot be removed by surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryosurgery | Procedure | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cryosurgery
- description
- cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.
- interventionNames
- Procedure: cryosurgery
- Procedure: positron emission tomography
Primary outcomes (2)
- measure
- Local Failure Rates by CT Scan
- timeFrame
- at 3, 6, and 12 months
- description
- Local Failure Rates by CT Scan Assessed as Percentage of Participants with Local Recurrence
- measure
- Distant Failure Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant pulmonary neoplasm * New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed * Imaging findings compatible with localized treatment failure after prior cryotherapy allowed * Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy * Metastatic disease must meet all of the following criteria: * Primary tumors have been resected or have been deemed controlled by other therapies * No other widespread metastases evident (e.g., multiple hepatic or brain metastases) * Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach * No more than 5 targeted masses for study therapy * Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass \> 1 cm, but \< 10 cm in average diameter * Unresectable disease by surgical consultation OR patient refused surgical options * Nonenhanced and enhanced CT scan required within the past 6 weeks done at 4-5 mm increments with available soft tissue and mediastinal windows to assess size and extent of all thoracic tumors * PET scan required within the past 6 months noting the correlation with the above CT locations, if not already obtained by a combined PET/CT scanner PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) \> 60-100% OR WHO/ECOG/Zubrod PS 0-2 * FEV\_1 \> 30% of predicted * DLCO \> 40% of predicted * Platelet count ≥ 70,000/mm\^3 * INR \< 1.5 * No uncontrolled coagulopathy or bleeding diathesis * Not pregnant or nursing * Negative pregnancy test * No serious medical illness, including any of the following: * Uncontrolled congestive heart failure * Uncontrolled angina * Myocardial infarction * Cerebrovascular event within 6 months prior to study entry * No medical contraindication or potential problem that would preclude study compliance PRIOR CONCURRENT THERAPY: * At least 7 days since prior aspirin and aspirin-like medications * At least 3 days since prior warfarin, clopidogrel bisulfate, or similar compounds * No concurrent drugs causing bleeding tendencies (e.g., aspirin, warfarin, or clopidogrel bisulfate) * No concurrent participation in other experimental studies
References
Publications (0)
Data not yet available