Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Sorafenib

Alovudine

Antiviral Agents

Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial). We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (\< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.

Cohort 2 will include patients treated with standard WBRT alone. Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to \[18F\] FLT PET at baseline (\< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.

All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.

Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.

Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.

18F-FLT-PET Imaging

Andrew Seidman, MD

The purpose of this study is to compare two different imaging methods to examine the response of brain metastases to WBRT. These two imaging methods will take pictures of the brain using : 1) a positron emission tomography (PET) scanner and 2) Magnetic Resonance Imaging (MRI) scanner. A PET scanner resembles a CT or MR scanner.PET scans use radioactive substances also called as radioactive markers to "see" cancer cells. We plan to use \[18F\]FLT as a radioactive marker. FLT is used to image tumor growth. FLT PET scan is a new clinical procedure. It is in the testing stage of development unlike FDG-PET which is used more commonly used. Therefore, this is considered a "research" study. This will help us evaluate whether this scan will be safe and better used in the future to evaluate tumors. The amount of radiation to the body is small. The radiation from the radiotracer drug will be gone from the body in a few hours. There is no radiation risk from the MRI scans. Additionally, we also plan to use MRI imaging of the brain. We expect that \[18F\]FLT PET is better when compared to MRI and will give us more information about the brain metastases after WBRT.

18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain

Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain

Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)

Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis. In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies. For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.

Memorial Sloan Kettering Cancer Center

12-039 is a companion FLT-PET brain imaging study to 12-046.

Cohort 1

Cohort 2

All participants will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.

Participants will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.

Participants will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Andrew Seidman, MD

Participants With Metastatic Breast Cancer

12-039 is a companion FLT-PET brain imaging study to 12-046.

10 participants from 12-046 were consented to 12-039. 10 other participants were approached for FLT-PET brain imaging getting standard WBRT off of 12-046, (without sorafenib), as a comparator group (not "arm").

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain	NCT01621906	Metastatic Brea...	18F-FLT-PET Ima... 18F-FLT-PET Ima...	18 Years -	Memorial Sloan Kettering Cancer Center
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain	NCT01621906	Metastatic Brea...	18F-FLT-PET Ima... 18F-FLT-PET Ima...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for metastatic breast cancer to the brain