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

21 Years
80 Years
Open (Enrolling)
Liver Cancer

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Trial Information

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

Inclusion Criteria:

- Patient eligible to receive external beam intensity modulated radiotherapy for liver

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Yoshiya Yamada, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Liver Cancer
  • Anesthesia
  • suspended ventilation
  • Liver Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021