A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonanc… (NCT06130280) | Clinical Trial Compass
RecruitingPhase 2
A Study of Single Fraction Stereotactic Body Radiation Therapy (SBRT) Guided by Magnetic Resonance Imaging (MRI) in People With Liver Metastasis From Colorectal Cancer
United States32 participantsStarted 2023-11-08
Plain-language summary
The researchers are doing this study to see if one session of high-dose contrast-enhanced MRI-guided SBRT (stereotactic body radiation therapy) is effective for colorectal cancer that has spread to the liver. The researchers will evaluate how well the study treatment can prevent the liver metastasis from growing and spreading. In addition, they will see whether it causes any side effects and whether there are any characteristics of the research MRI images that can predict response to treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18
* Histologically confirmed colorectal carcinoma and evidence of liver metastasis on imaging
* ECOG 0-2
* \<=3 liver lesions measurable on contrast enhanced diagnostic MRI with combined size (sum of longest diameters) \< 7 cm, and individual size \< 5cm. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in size exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning).
* Lesion location at least ≥ 2 cm of main, right and left portal vein on the baseline diagnostic MRI. (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning ).
* Lesion location at least ≥ 1.5 cm of luminal gastrointestinal tract (stomach, small and large bowel). (Subsequent simulation scans will not be used for eligibility assessment. In case of significant change in the distance between the lesion edge and critical structure exceeding 1cm, the individual participants can continue on the protocol provided all normal tissue contraints are met during planning).
* Lesion location ≥ 0.5 cm of diaphragm
* Preserved liver function as defined by:
* Albumin \> 2 g/dl
* \< AST/ ALT ≤ 5 x ULN
* Total Bilirubin ≤ 1…