NCT02465723

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

June 4, 2015

Last Update Submit

September 20, 2016

Conditions

Metastatic Disease to BoneMetastatic Disease to Soft Tissue

Keywords

Intravoxel Incoherent Motion (IVIM)Diffusion-weighted Magnetic ResonanceAcid Sphingomyelinase/Ceramide Pathway Activation15-104

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • C16 serum ceramide levels

    1 year

  • C18 serum ceramide levels

    1 year

Study Arms (1)

MRI with IVIM DW-MRI

EXPERIMENTAL

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.

Device: MRI with IVIM DW-MRIOther: Blood draw

Interventions

MRI with IVIM DW-MRIDEVICE
MRI with IVIM DW-MRI
Blood drawOTHER

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.

MRI with IVIM DW-MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Hebert A. Vargas, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 8, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

US(1)