Clinical trial NCT02465723: Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
Official title: Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metastatic Disease to Bone
Metastatic Disease to Soft Tissue
Keywords: Intravoxel Incoherent Motion (IVIM)
Diffusion-weighted Magnetic Resonance
Acid Sphingomyelinase/Ceramide Pathway Activation
15-104
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: ASMase activity measurement
timeFrame: up to 18-24 hours after the first radiation treatment
Secondary outcomes:
measure: C16 serum ceramide levels
timeFrame: 1 year
measure: C18 serum ceramide levels
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hebert A. Vargas, MD
role: PRINCIPAL_INVESTIGATOR
References: