Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers

Withdrawn before enrolling · Not applicable

Conditions studied: Metastatic Disease to Bone, Metastatic Disease to Soft Tissue

In brief

The 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.

Key facts

Study ID

NCT02465723

Run by

Memorial Sloan Kettering Cancer Center

People needed

0

Starts

2015-06-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven cancer
• 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.

You may not qualify if…

• Pregnant patients
• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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