Metastatic Disease to BoneNCT02465723
Detection of Acid Sphingomyelinase/Ceramide Pathway Activation in Radiotherapy Patients Using Intravoxel Incoherent Motion (IVIM) Diffusion-weighted Magnetic Resonance Imaging and Serum Biomarkers
A study testing MRI with IVIM DW-MRI and Blood draw in people with Metastatic Disease to Bone and Metastatic Disease to Soft Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Disease to Bone, Metastatic Disease to Soft Tissue
- What is being tested?
- MRI with IVIM DW-MRI and Blood draw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Being tested
- MRI with IVIM DW-MRI, Blood draw
- Keywords
- Intravoxel Incoherent Motion (IVIM), Diffusion-weighted Magnetic Resonance, Acid Sphingomyelinase/Ceramide Pathway Activation, 15-104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with IVIM DW-MRIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI with IVIM DW-MRI; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 18-24 hours after the first radiation treatment
Secondary outcomes (2)
C16 serum ceramide levels
Total C16 serum ceramide level, expressed as ng of ceramide per mL, will be measured for the pre-RT serum and post-RT serum. For each patient, the post-RT C16 ceramide level will be expressed as a fraction of the pre-RT levels.
Measured: 1 year
C18 serum ceramide levels
Total C18 serum ceramide level, expressed as ng of ceramide per mL, will be measured for the pre-RT serum and post-RT serum. For each patient, the post-RT C18 ceramide level will be expressed as a fraction of the pre-RT levels.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
Why it stopped: Lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Disease to BoneStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hebert A. Vargas, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465723
- Sponsor's protocol ID
- 15-104
- Status last verified
- Sep 2016
- First submitted
- 4 Jun 2015
- Last updated
- 21 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02465723
- Acronym / sponsor ID
- 15-104
- Keywords
- Intravoxel Incoherent Motion (IVIM), Diffusion-weighted Magnetic Resonance, Acid Sphingomyelinase/Ceramide Pathway Activation, 15-104
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI with IVIM DW-MRI | Experimental | Device: MRI with IVIM DW-MRI, Other: Blood drawUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI with IVIM DW-MRI | Device | MRI with IVIM DW-MRI |
| Blood drawFor 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. | Other | MRI with IVIM DW-MRI |
Primary outcome
ASMase activity measurement
Time frame: up to 18-24 hours after the first radiation treatment
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.
2 secondary outcomes
C16 serum ceramide levels
Time frame: 1 year
C18 serum ceramide levels
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hebert A. Vargas, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI with IVIM DW-MRI and Blood draw in people with Metastatic Disease to Bone and Metastatic Disease to Soft Tissue, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASMase activity measurement (time frame: up to 18-24 hours after the first radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.