Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01621906 : 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
PhaseN/A
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01621906      |      Link to official Clinicaltrials.gov listing
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