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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | 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
