CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
FACBC, Methionine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00597246
NCT00597246N/ACompleted

Imaging Brain Tumors With FACBC and Methionine

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 18, 2008·Updated Dec 17, 2020

In Brief

A clinical study evaluating FACBC, Methionine and PET Scan for Brain Cancer and CNS Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

This research protocol makes pictures of brain tumors. The pictures are made with a positron emission tomography (PET) scanner. PET scans use radioactivity to "see" cancer cells. We are using a new kind of PET scan. The new PET scan is called \[18F\]-FACBC PET. We will compare this to the standard PET scan. The standard PET scan is called \[11C\]-methionine PET. We expect these pictures will give us information about your tumor. We also hope to collect information about the amount of radioactivity exposure. We will measure radioactivity exposure to your tumor, brain and other organs. The research study results will be used to support the submission of an investigational new drug (IND) application to the Food and Drug Administration (FDA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2008
Enrollment StartMay 13, 2003
Primary CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 16.5 yearsPosted 18.5 years ago

Interventions

FACBC, Methioninedrug

F-18 labeled FACBC is prepared stereo-specifically in a semi-automated, NCA procedure utilizing the General Electric FDG MicroLab, a system employing a quaternary 4-aminopyridinium resin to effect F-18 fluorination. The triflate species is displaced with F-18 fluoride in the MicroLab, and then the 1-t-butyl carbamate-3- trifluoromethane sulfonoxy-1-cyclobutane-1-carboxylic acid methyl ester is hydrolyzed with 1 N HCl. The final product is isotonic and sterile, and has been utilized in animal experiments. The product was obtained in 30% radiochemical yield after 65 minutes from EOB. The radiochemical purity was greater than 95% and no preparative HPLC was required. The procedure could be considered routine, and is performed on the FDG synthetic module without changes either to the programming or to the cassettes.

PET Scanother

GE Advance PET scanner for sequential body imaging