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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02277561
• Other study ID #: 13-01-047
• Secondary ID: NCI-2014-0101513
• Status: Withdrawn
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

PRIMARY OBJECTIVES:

I. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Neoplasms
• Tumors Metastatic to Brain
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• diffusion tensor imaging
Undergo VB-DTI

Radiation:
• whole-brain radiation therapy
Undergo WBRT
• stereotactic radiosurgery
Undergo SRS

Procedure:
• contrast-enhanced magnetic resonance imaging
Undergo contrast-enhanced MRI
• diffusion-weighted magnetic resonance imaging
Undergo DW MRI

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion		Up to 3 years
Primary	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.	At 4 months
Primary	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.	At 4 months
Primary	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.	Baseline to 4 months