Liver CancerNCT00774501
The Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
A study testing image guidance with general anesthesia and suspended ventilation during treatment delivery in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- image guidance with general anesthesia and suspended ventilation during treatment delivery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study to Assess 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.
- Conditions
- Liver Cancer
- Being tested
- image guidance with general anesthesia and suspended ventilation during treatment delivery
- Keywords
- Anesthesia, suspended ventilation
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image guidance with general anesthesia and suspended ventilation during treatment deliveryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment of metastatic liver disease | Experimental | 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. Receives: Procedure: image guidance with general anesthesia and suspended ventilation during treatment delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshiya Yamada, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774501
- Sponsor's protocol ID
- 08-117
- Status last verified
- Feb 2016
- First submitted
- 16 Oct 2008
- Last updated
- 18 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of Using Anesthesia and Suspended Ventilation to Immobilize Liver Tumors During Radiotherapy
- ClinicalTrials.gov ID
- NCT00774501
- Acronym / sponsor ID
- 08-117
- Conditions
- Liver Cancer
- Keywords
- Anesthesia, suspended ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment of metastatic liver disease | Experimental | Procedure: image guidance with general anesthesia and suspended ventilation during treatment deliveryThe 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| image guidance with general anesthesia and suspended ventilation during treatment deliveryAll 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. | Procedure or surgery | treatment of metastatic liver disease |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiya Yamada, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing image guidance with general anesthesia and suspended ventilation during treatment delivery in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: conclusion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.