NCT02465723|Withdrawn
Study Stopped
Lack of accrual
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Sponsor study identifier
interventional
0
1 country
1
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
Not reported
Date not reportedThe purpose of this study is to find out if special blood tests and imaging scans can help evaluate the effects of the radiation the patient receives as part of standard treatment. The patient will undergo either stereotactic or conventional radiation treatment as determined by the treating doctor. Previous evidence suggests that blood flow to tumors is affected by the amount (dose) of radiation that it receives. This effect may be seen as soon as 1-2 hours after the radiation is given. This study will evaluate if these changes can be seen and measured by performing a special type of scan called Intravoxel Incoherent Motion (IVIM) diffusion-weighted Magnetic Resonance Imaging (MRI) and a blood test. IVIM MRI is a research exam which is similar to a standard MRI exam, with only a slight difference in the technical parameters used to acquire the images.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
June 4, 2015
Actual (reported)June 8, 2015
Actual (reported)June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ASMase activity measurement
For each serum ASMase activity measurement, we will use 3 technical assay replicates. Each of three replicates will be averaged. Then the post-treatment activity will be normalized (fraction) against its paired pre-treatment activity.
up to 18-24 hours after the first radiation treatment
C16 serum ceramide levels
1 year
C18 serum ceramide levels
1 year
Upon enrollment in the study, each patient will undergo a standard pre-treatment evaluation in the Radiation Oncology Clinic. Imaging will include MRI with IVIM DW-MRI (as a research exam). MR imaging will begin within 30 minutes (+/- 15 mins) of the completion of single-dose radiation or the first dose for patients treated with a multifractioned regime. Patients will have corresponding serum samples collected at approximately 1 hour before and 18-24 hours after the first radiation treatment. If radiation therapy occurs on a Friday, the collection of the serum 18-24 hours post-treatment may still be feasible. Patients will be treated with radiation therapy according to our standard clinical guidelines using one of several Varian megavoltage linear accelerators with on-board kilovoltage image-guidance capabilities, using established immobilization devices that are specific to the anatomical site treated at MD's discretion.
For each patient enrolled, 8-10 mL of whole blood will be collected into glass, anti-coagulant-free tubes and allowed to clot 20-30 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Hebert A. Vargas, MD
Memorial Sloan Kettering Cancer Center
0 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2015
First Posted
June 8, 2015
Study Start
June 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 21, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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