Localize Liver Metastases
Conditions
Keywords
Radiation Therapy
Brief summary
The purpose of this study is to test a new and possibly more accurate method of positioning patients with liver tumors in preparation for radiation treatment. The positioning of patients with liver cancer is important because the tumor moves a bit when you breathe and makes it hard to determine the right position of the tumor at the time of treatment. Also, depending upon what is in your stomach at the time of treatment, it may change the shape of the liver and make it difficult to plan the radiation treatment. As part of this study, we will take a new type of image of your liver in addition to the standard portal images. This new type of image is called a cone-beam image. It shows a much more detailed picture of the liver tumors than the standard portal images. Normally, marker seeds need to be placed near the liver metastasis for radiation treatment. If the results of this study show that the tumor can be positioned as accurately with the new images as with the old images, then future patients with liver tumors would not have to have marker seeds placed into their liver. The use of cone beam imaging for the setup of patients with liver tumors is new.
Interventions
RADIATIONcone beam imaging
All study patients will undergo simulation, treatment planning and verification as currently practiced. The contrast injection and cone beam imaging will be added to the standard procedure just prior to treatment delivery on the first and last days of treatment only.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Age \> than or equal to 18 years * KPS \> than or equal 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
Exclusion criteria
* Lymphoid primary histology (lymphoma/leukemia) * Allergic reaction to intravenous CT contrast * Liver function tests (AST, ALT, Bilirubin) \> 2.0 x normal * Abnormal kidney function (serum creatinine \> 1.5) * INR \> 2.0, Platelet count \<70.000. * Marker seed placement not possible * \> 5mm excursion after abdominal compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Eligible for Cone Beam Tumor Localization | Up to 2 hours | Assess the feasibility of using a new imaging technique called cone beam imaging to localize a liver tumor immediately prior to external beam radiotherapy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Going for Treatment of Liver Metastases With RT Patients going for treatment of liver metastases with radiation therapy. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Deviation | 1 |
Baseline characteristics
| Characteristic | Patients Going for Treatment of Liver Metastases With RT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants Eligible for Cone Beam Tumor Localization
Assess the feasibility of using a new imaging technique called cone beam imaging to localize a liver tumor immediately prior to external beam radiotherapy.
Time frame: Up to 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Going for Treatment of Liver Metastases With RT | Number of Participants Eligible for Cone Beam Tumor Localization | 5 participants |