The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

image guidance with general anesthesia and suspended ventilation during treatment delivery

Procedure

All study patients will undergo marker implantation approximately 2 weeks prior to the PET-CT simulation and treatment planning. PET-CT is performed for treatment planning purposes. This part of the process is in routine clinical use at MSKCC.

Three cone beam imaging scans and an IV contrast injection just prior to the first cone beam scan will be added to the standard procedure. The use of these two techniques is investigational.

The treatment delivery will make use of general anesthesia and suspension of mechanical ventilation to render the patient apneic during both target localization and dose delivery. This will allow the dose to be delivered more precisely than the techniques currently in use, thus allowing the use of smaller treatment margins and reducing the high dose exposure of healthy liver tissue. These measures have not previously been used for treatment delivery.

Primary outcomes

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.

Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Oct 17, 2008
Registry last updated: Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed