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Tumors Metastatic to BrainNCT02277561

Voxel Based Diffusion Tensor Imaging in Predicting Response in Patients With Brain Metastases Undergoing Whole Brain Radiation Therapy or Stereotactic Radiosurgery

A study testing diffusion tensor imaging, whole-brain radiation therapy and stereotactic radiosurgery in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Albert Einstein College of Medicine at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
diffusion tensor imaging, whole-brain radiation therapy and stereotactic radiosurgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2013to Dec 2014
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with multiple lesions from solid tumors on clinical MRI diagnosing the brain metastases may be treated with either WBRT or SRS if clinically indicated at the time of presentation but not both
  • Karnofsky performance status (KPS) >= 70
  • Patients presenting with brain metastases from a newly diagnosed cancer may have systemic disease (brain disease at the time of initial cancer diagnosis)
  • Patients with a history of cancer, but newly diagnosed brain metastases must have clinically stable systemic disease
  • If a biopsy is performed, the patient has to be at least 1 week post-biopsy
  • The patient must be able to commit to diffusion-weighted magnetic resonance (MR) imaging, diffusion tensor imaging (DTI), and chemical shift imaging (CSI) prior to treatment, after the first week of treatment, and 7-11 days after the completion of treatment at the Magnetic Resonance Research Center (MRRC)
  • Patients undergoing SRS without WBRT must be able to commit to diffusion-weighted MR imaging, DTI, and CSI prior to treatment, and 7-11 days after the completion of the SRS treatment at the MRRC
  • The patient must also be able to commit to post-treatment follow-up visits at Montefiore Medical Center involving serial MR imaging; the follow-up visits are to occur bimonthly for 6 months and then every 6 months until death

Who cannot join

  • Any medical condition, which would make the imaging studies or WBRT unsafe or poorly tolerated
  • Patient is receiving concurrent chemotherapy
  • Known allergic reaction to contrast or shellfish
  • Patients with brain metastases to be treated with radiosurgery
  • Patients with brain metastasis resulting from hematologic malignancies and small cell lung cancer
  • Implanted metal devices or foreign bodies that serve as a contraindication to MR imaging
Show all 13Show fewer
  • Creatinine > 1.4 mg/dl and creatinine clearance < 20 mg/dl
  • Uncontrolled, clinically significant cardiac arrhythmias
  • Severe claustrophobia
  • Pregnant female
  • Any prior radiation therapy to the brain
  • KPS < 70
  • Patients with leptomeningeal disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Prediction of Response of Brain Metastases to Brain Irradiation Using Voxel Based Diffusion Tensor Imaging

This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.

OUTLINE:

Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.

After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.

Being tested
diffusion tensor imaging, whole-brain radiation therapy, stereotactic radiosurgery, contrast-enhanced magnetic resonance imaging, diffusion-weighted magnetic resonance imaging
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • diffusion tensor imagingProcedure or surgery

    Undergo VB-DTI

  • whole-brain radiation therapyRadiation

    Also called WBRT, whole-brain radiotherapy

    Undergo WBRT

  • stereotactic radiosurgeryRadiation

    Undergo SRS

  • contrast-enhanced magnetic resonance imagingProcedure or surgery

    Also called Contrast-enhanced MRI

    Undergo contrast-enhanced MRI

  • diffusion-weighted magnetic resonance imagingProcedure or surgery

    Also called diffusion-weighted MRI

    Undergo DW MRI

Study groups in NCT02277561
Study groupRoleWhat they receive
Diagnostic (VB-DTI, MRI)ExperimentalPatients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
Receives: Procedure: diffusion tensor imaging; Radiation: whole-brain radiation therapy; Radiation: stereotactic radiosurgery; Procedure: contrast-enhanced magnetic resonance imaging; Procedure: diffusion-weighted magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion

    Measured: Up to 3 years

  2. Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion

    Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05.

    Measured: At 4 months

  3. Volumetric radiographic response for each lesion

    Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05.

    Measured: At 4 months

  4. Change in a lesion's overall mean ADC

    Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05.

    Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Why it stopped: IRB approved but never implemented

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02277561
Sponsor's protocol ID
13-01-047
Other IDs
NCI-2014-01015, 13-01-047, P30CA013330
Status last verified
Mar 2020
First submitted
27 Oct 2014
Last updated
4 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing diffusion tensor imaging, whole-brain radiation therapy and stereotactic radiosurgery in people with Tumors Metastatic to Brain and Unspecified Adult Solid Tumor, Protocol Specific, run by Albert Einstein College of Medicine 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 8 inclusion and 13 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 4 Mar 2020. 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?

Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02277561.

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 4 Mar 2020; AzTrials last refreshed its copy on 28 Oct 2026.

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