Clinical trial · Interventional
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
NCT00774501CI-TRIAL-00020972completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Liver tumors are hard to treat with radiation because the liver moves every time you breathe. The purpose of this study is to test a new and possibly more accurate way of treating liver tumors. When a person is asleep under anesthesia, it is safe to stop breathing motion for a while. The liver will stop moving and radiation can be given to a liver tumor. The study is being done to see if radiation can be given to liver tumors safely and accurately in this way.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| image guidance with general anesthesia and suspended ventilation during treatment delivery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment of metastatic liver disease
- description
- The intervention is the use of image guidance with general anesthesia and suspended ventilation during treatment delivery. This will allow precise localization and delivery of dose to the tumor.
- interventionNames
- Procedure: image guidance with general anesthesia and suspended ventilation during treatment delivery
Primary outcomes (1)
- measure
- To assess safety & feasibility of single dose image-guided intensity modulated radio (IG-IMRT) using gen anesthesia with apneic oxygenation & controlled ventilation to temp suspend respiratory motion for tx of mets liver disease during localization & tx.
- timeFrame
- conclusion of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient eligible to receive external beam intensity modulated radiotherapy for liver cancer * Age:21\<80 * KPS \> or = to 80 * Able to tolerate immobilization cradle positioning * Able to give informed consent * Histologically confirmed diagnosis of solid tumor malignancy * Liver metastases visualized on CT imaging (obtained within approximately 6 months from enrollment). * Target lesion ≤ or = to 8 cm in maximal diameter * In the case of multiple liver metastases, only one lesion will be targeted per treatment session. Typically the target lesion will be the lesion which is progressing or the cause of symptoms. The target lesion will be picked in consultation with the referring physician. Exclusion Criteria: * Lymphoid primary histology (lymphoma/leukemia) * Single metastasis in an operable patient. Operable lesions will only be considered for enrollment in the protocol if the patient refuses resection of the metastasis. * Target lesion \> 8 cm in maximal diameter * Cirrhosis of the liver (Child's C) * Liver function enzymes (AST, ALT) \> 3x normal , obtained within 1 month of treatment. * \< 500 cc uninvolved liver * Unable to tolerate intravenous CT contrast * Serum Hemoglobin \< 9.0 (obtained within 1 month of treatment) * Presence of untreated brain metastases * Severe pulmonary disease (O2 dependent, unable to walk a flight of stairs) * Unstable cardiac status * Unstable angina * Significant abnormal 12 lead EKG (non sinus arrhythmia or ischemia unsuitable for general anesthesia) * Congestive Heart Failure * Abnormal kidney function (serum creatinine \> 1.5) obtained within 1 month of treatment * Platelet count \<70.000. (obtained within 1 month of treatment). * INR \> 2.0 (obtained within 1 month of treatment) * Marker seed placement not possible * Implanted defibrillator/pacemaker * Evidence of increased intracranial pressure * Significant ascites * Morbid Obesity * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.