Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
NCT ID: NCT02465723
Last Updated: 2016-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MRI with IVIM DW-MRI
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.
MRI with IVIM DW-MRI
Blood draw
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.
Interventions
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MRI with IVIM DW-MRI
Blood draw
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.
Eligibility Criteria
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Inclusion Criteria
* Patients deemed clinically appropriate for radiation treatment as part of the standard care provided by their treating physician, and will receive either 24 Gy (one fraction) or 3 Gy x 10 fractions.
* Life expectancy \> 6 months
* KPS\>60%
* Age ≥ 18 years old.
Exclusion Criteria
* Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc
* Prior radiotherapy to the site of intended treatment
* Patients with tumor involving brain or spinal cord
* Platelet count \<75,000/μl, HgB level \<9 g/dl, WBC \<3500/μl
* Presence of metastases in the upper thoracic spine (in order to avoid DW- MRI parameter measurement variability due to cardiac motion)
* Lesions \<1.5 cm (to assure robust measurements)
* Non-English speaking patients
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Hebert A. Vargas, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-104
Identifier Type: -
Identifier Source: org_study_id
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