Imaging Brain Tumors With FACBC and Methionine
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this research is to: 1) perform both 3-[18F]-FACBC and [11C-methyl]-Lmethionine brain tumor PET imaging studies in patients with primary brain tumors who have previously been treated and are now suspect for having recurrence or progression of disease (a pilot study, n=20); 2) perform only 3-[18F]-FACBC PET imaging studies on an additional set of patients with primary brain tumors who have previously been treated and are now suspect for having recurrence (n=10) . 3) obtain organ/tissue and body radiation dosimetry information following i.v. injection of 3-[18F]-FACBC; 4) look for potential correlations between the scan results obtained from those patients enrolled to 03-028 and the patients' past medical treatment; The first set of 20 patients will agree to two PET studies. One study will involve the i.v.
administration of a fluorine-18 labeled amino acid analogue, 3-fluoro-aminocyclobutane carboxylic acid (3-[18F]-FACBC) with sequential brain and body PET imaging. The second study will involve i.v. administration of [11C-methyl]-L-methionine and head imaging only.
The additional set of 10 patients will undergo one PET study which will consist of the i.v.
administration of fluorine-18 labeled amino acid analogue, 3-fluoro-aminocyclobutane carboxylic acid (3-[18F]-FACBC) with one brain scan and one body scan only. The 3-[18F]-FACBC PET studies (n=30) will be performed under the Radioactive Drug Research Committee (RDRC) guidelines as defined and established by the Federal Drug Administration (FDA). [11C-methyl]-L-methionine is in the hospital formulary and is approved for imaging brain tumors at MSKCC. Our hypotheses include: 1) [18F]-FACBC has equal or better brain tumor imaging characteristics compared to [11C]-methionine; 2) [18F]-FACBC is not metabolized, and radiolabeled metabolites will not confound the interpretation of the images as can be the case with [11C]-methionine; 3) imaging recurrent brain tumors with [18F]-FACBC will be enhanced by lower brain (background) activity as compared to corresponding [11C]- methionine images; 4) the biodistribution of [18F]-FACBC and radiation dosimetry following i.v. administration of a 370 MBq (10 mCi) dose is safe and within FDA guidelines; 5) a 370 MBq (10 mCi) dose of [18F]-FACBC is sufficient for imaging brain tumors in a clinical setting; 6) the accumulation of [18F]-FACBC will correlate with the patients response to prior treatment and will provide prognostic information with respect to tumor progression and survival.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: 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.
Other: PET Scan
GE Advance PET scanner for sequential body imaging
|
Outcome Measures
Primary Outcome Measures
- Maximum Standardized Uptake Value of 3-[18F]-FACBC [Duration of scan, an average of 1 hour]
Determine clearance of 3-[18F]-FACBC in different tissues/organs of body.
Secondary Outcome Measures
- Rate of 18F-Fluciclovine Transport (k1) Into Tumors [Duration of scan, an average of 1 hour]
Look for potential correlations bet subsequent MR & PET results obtained from patients enrolled and patients' subsequent medical treatment, progression of tumor & survival.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Registered patient at MSKCC.
-
Child-bearing age females must be non-pregnant, non-lactating, and must be using adequate contraception or surgically sterile.
-
Karnofsky score of 60 or greater.
-
Children that can sit still for 60-90 minutes, without sedation, will be included in this protocol.
Exclusion Criteria:
- Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Ronald blasberg, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 03-028
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Participants With Brain Tumors |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Participants With Brain Tumors |
|---|---|
| Arm/Group Description | 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 Participants | 30 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
54
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
30%
|
| Male |
21
70%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
3.3%
|
| Not Hispanic or Latino |
29
96.7%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
3.3%
|
| White |
27
90%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
6.7%
|
| Region of Enrollment (Count of Participants) | |
| United States |
30
100%
|
Outcome Measures
| Title | Maximum Standardized Uptake Value of 3-[18F]-FACBC |
|---|---|
| Description | Determine clearance of 3-[18F]-FACBC in different tissues/organs of body. |
| Time Frame | Duration of scan, an average of 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| 3 participants did not receive 18F-Fluciclovine PET studies |
| Arm/Group Title | Participants With Brain Tumors |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 27 |
| Mean (Standard Deviation) [SUVmax] |
4.5
(2.3)
|
| Title | Rate of 18F-Fluciclovine Transport (k1) Into Tumors |
|---|---|
| Description | Look for potential correlations bet subsequent MR & PET results obtained from patients enrolled and patients' subsequent medical treatment, progression of tumor & survival. |
| Time Frame | Duration of scan, an average of 1 hour |
Outcome Measure Data
| Analysis Population Description |
|---|
| 3 participants did not receive PET scans |
| Arm/Group Title | Participants With Brain Tumors |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 27 |
| Mean (Standard Deviation) [mL/min/g] |
0.14
(0.24)
|
Adverse Events
| Time Frame | Up to 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Participants With Brain Tumors | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Participants With Brain Tumors | ||
| Affected / at Risk (%) | # Events | |
| Total | 29/30 (96.7%) | |
Serious Adverse Events |
||
| Participants With Brain Tumors | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Participants With Brain Tumors | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/30 (6.7%) | |
| Investigations | ||
| Lymphopenia | 1/30 (3.3%) | |
| Prothrombin Time/PT | 1/30 (3.3%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Ronald Blasberg, MD |
|---|---|
| Organization | Memorial Sloan Kettering Cancer Center |
| Phone | 646-888-2211 |
| blasberr@mskcc.org |
- 03-028