Trial Outcomes & Findings for Imaging Brain Tumors With FACBC and Methionine (NCT NCT00597246)

NCT ID: NCT00597246

Last Updated: 2020-12-17

Results Overview

Determine clearance of 3-\[18F\]-FACBC in different tissues/organs of body.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

Duration of scan, an average of 1 hour

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Brain Tumors FACBC, Methionine: 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 Scan: GE Advance PET scanner for sequential body imaging
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imaging Brain Tumors With FACBC and Methionine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Brain Tumors n=30 Participants FACBC, Methionine: 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 Scan: GE Advance PET scanner for sequential body imaging
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of scan, an average of 1 hour

Population: 3 participants did not receive 18F-Fluciclovine PET studies

Determine clearance of 3-\[18F\]-FACBC in different tissues/organs of body.

Outcome measures

Outcome measures
Measure	Participants With Brain Tumors n=27 Participants FACBC, Methionine: 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 Scan: GE Advance PET scanner for sequential body imaging
Maximum Standardized Uptake Value of 3-[18F]-FACBC	4.5 SUVmax Standard Deviation 2.3

SECONDARY outcome

Timeframe: Duration of scan, an average of 1 hour

Population: 3 participants did not receive PET scans

Look for potential correlations bet subsequent MR \& PET results obtained from patients enrolled and patients' subsequent medical treatment, progression of tumor \& survival.

Outcome measures

Outcome measures
Measure	Participants With Brain Tumors n=27 Participants FACBC, Methionine: 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 Scan: GE Advance PET scanner for sequential body imaging
Rate of 18F-Fluciclovine Transport (k1) Into Tumors	0.14 mL/min/g Standard Deviation 0.24

Adverse Events

Participants With Brain Tumors

Serious events: 0 serious events

Other events: 2 other events

Deaths: 29 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With Brain Tumors n=30 participants at risk FACBC, Methionine: 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 Scan: GE Advance PET scanner for sequential body imaging
Investigations Lymphopenia	3.3% 1/30 • Up to 1 year
Investigations Prothrombin Time/PT	3.3% 1/30 • Up to 1 year

Additional Information

Ronald Blasberg, MD

Memorial Sloan Kettering Cancer Center

Phone: 646-888-2211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place