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



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/7/2018
Start Date:June 2012
End Date:June 2019
Contact:Andrew Seidman, MD
Phone:646-888-5445

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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

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.


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.

- No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation
of WBRT. Please note: there is no washout period required for trastuzumab, pertuzumab,
for patients who have developed new parenchymal brain metastases while on these
agents.

Exclusion Criteria:

- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it
is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of
enrollment, to show that no other leptomeningeal metastases is present) and is not the
only metastasis present in the brain.

- 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
We found this trial at
6
sites
1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Phone: 646-888-5445
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Basking Ridge, New Jersey
Phone: 646-888-5445
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Commack, New York 11725
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500 Westchester Avenue
Harrison, New York 10604
Phone: 646-888-5445
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Middletown, New Jersey 07748
Phone: 646-888-5445
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrew Seidman, MD
Phone: 646-888-5445
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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