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

Description

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 the researchers 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.

Study Start Date

June 2012

Estimated Completion Date

June 2017

Interventions

  • Device: 18F-FLT-PET Imaging

Specialties

  • Neurology: Neurologic Oncology,Neuroradiology
  • Oncology: Breast,Diagnostics/Radiology,Neurologic Oncology
  • Radiology: CT/SPECT/PET,MRI,Neuroradiology

MeSH Terms

  • Breast Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasm Metastasis
  • Neuroradiography

Study ID

Memorial Sloan-Kettering Cancer Center -- 12-039

Status

Unknown

Trial ID

NCT01621906

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

20

Sponsor

Memorial Sloan-Kettering Cancer Center

Inclusion Criteria

  • Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
  • Radiologic evidence of new and/or progressive brain metastases (>10 mm in longest dimension) by MRI imaging of the Brain
  • Planned WBRT based on number (? 3 lesions) and/or size (? 1 cm) of brain metastases.
  • Age ?18 years
  • males and females
  • Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
  • Life expectancy of >12 weeks.
  • Karnofsky Performance Status (KPS) ? 70%.
  • Creatinine ?2.0 times the upper limit of normal.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.

Exclusion Criteria

  • Leptomeningeal metastases
  • Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
  • Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
  • Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
  • Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
  • Inability to comply with protocol and /or not willing or not available for follow-up assessments.
  • Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.
  • Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
  • Claustrophobia
  • Known allergic reaction to Gd-DTPA
  • Renal insufficiency with recent (<3 month old) creatinine >2.0

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center Suffolk - Commack, New York 26.2 miles Andrew Seidman MD 646-888-5445 None
Memorial Sloan Kettering Cancer Center Suffolk - Commack, New York 26.2 miles None None None
Memorial Sloan Kettering West Harrison - West Harrison, New York 28.7 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Andrew Seidman MD 646-888-5445 None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles None None None

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