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.]

NCT01222728 : Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
PhaseN/A
AgesMin: 18 Years Max: 50 Years
Eligibility
- INCLUSION CRITERIA:

- Clinical diagnosis of NF2 by established clinical criteria or genetic testing.

- Age 18 to 50.

- A minimum of 3 intracranial tumors (meningiomas and/or VSs) measuring = or > 1cm in
size, including:

1. At least one unoperated VS > 1 cm in size AND

2. At least one unoperated meningioma > 1 cm in size

- No pregnancy or intent to become pregnant, with proper use of contraception for the
duration of the study.

- Normal liver enzymes: tests should be completed within 14 days before injection of
the radiopharmaceutical; SGOT, SGPT < 5x ULN; bilirubin less than or equal to 2x ULN

- If prior radiation therapy to the tumor: > 2 years must have passed after
radiotherapy administration and tumor must demonstrate growth after radiotherapy
(signifying a viable tumor for study is present)

- If prior chemotherapy: must have completed chemotherapy > 6 months prior to
enrollment to allow washout of chemotherapeutic agent

EXCLUSION CRITERIA:

- Clinically unstable condition that precludes serial clinical and imaging evaluation
(i.e. Class 3 congestive heart failure, severe chronic renal insufficiency, severe
chronic obstructive pulmonary disease).

- Contraindication to MRI scanning, including pacemakers or other implanted electrical
devices, brain stimulators, some types of dental implants, aneurysm clips (metal
clips on the wall of a large artery), metallic prostheses (including metal pins and
rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery
pump, or shrapnel fragments

- Severe chronic renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m2),
hepatorenal syndrome or post-liver transplantation.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01222728      |      Link to official Clinicaltrials.gov listing
Locations
Bethesda, Maryland
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
Investigator:
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) Phone: 800-411-1222
Click HERE to send email to this center




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