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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774501
• Other study ID #: 08-117
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: February 17, 2016
• Start date: October 2008
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		conclusion of study	Yes

External Links

•   Memorial Sloan Kettering Cancer Center