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

Primary Purpose

Liver Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
image guidance with general anesthesia and suspended ventilation during treatment delivery
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Anesthesia, suspended ventilation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment of metastatic liver disease

Arm 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.

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2008
Last Updated
February 17, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00774501
Brief Title
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Official Title
A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Anesthesia, suspended ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment of metastatic liver disease
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
image guidance with general anesthesia and suspended ventilation during treatment delivery
Intervention Description
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiya Yamada, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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