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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00774501
First received: October 16, 2008
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Liver Cancer
Procedure: image guidance with general anesthesia and suspended ventilation during treatment delivery

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: October 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment of metastatic liver disease
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.
Procedure: image guidance with general anesthesia and suspended ventilation during treatment delivery

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.


  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774501

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00774501     History of Changes
Other Study ID Numbers: 08-117
Study First Received: October 16, 2008
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Anesthesia
suspended ventilation

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014