Brain CancerNCT00597246
Imaging Brain Tumors With FACBC and Methionine
A study testing FACBC, Methionine and PET Scan in people with Brain Cancer and CNS Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Cancer, CNS Cancer
- What is being tested?
- FACBC, Methionine and PET Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2003to 27 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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).
Read the 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.
- Conditions
- Brain Cancer, CNS Cancer
- Being tested
- FACBC, Methionine, PET Scan
- Keywords
- Brain, CNS, Central Nervous System
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: FACBC, Methionine; Other: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Standardized Uptake Value of 3-[18F]-FACBC
Determine clearance of 3-[18F]-FACBC in different tissues/organs of body.
Measured: Duration of scan, an average of 1 hour
Secondary outcomes (1)
Rate of 18F-Fluciclovine Transport (k1) Into Tumors
Look for potential correlations bet subsequent MR \& PET results obtained from patients enrolled and patients' subsequent medical treatment, progression of tumor \& survival.
Measured: Duration of scan, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study start13 May 2003
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald blasberg, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597246
- Sponsor's protocol ID
- 03-028
- Status last verified
- Jun 2019
- First submitted
- 9 Jan 2008
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Brain Tumors With FACBC and Methionine
- ClinicalTrials.gov ID
- NCT00597246
- Acronym / sponsor ID
- 03-028
- Conditions
- Brain Cancer, CNS Cancer
- Keywords
- Brain, CNS, Central Nervous System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 May 2003 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FACBC, Methionine, Other: PET Scan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient cannot tolerate lying still for 90 minute sessions in the PET tomograph.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACBC, MethionineF-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. | Drug | 1 |
| PET ScanGE Advance PET scanner for sequential body imaging | Other | 1 |
Primary outcome
Maximum Standardized Uptake Value of 3-[18F]-FACBC
Time frame: Duration of scan, an average of 1 hour
Determine clearance of 3-[18F]-FACBC in different tissues/organs of body.
1 secondary outcome
Rate of 18F-Fluciclovine Transport (k1) Into Tumors
Time frame: Duration of scan, an average of 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald blasberg, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FACBC, Methionine and PET Scan in people with Brain Cancer and CNS Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Standardized Uptake Value of 3-[18F]-FACBC (time frame: Duration of scan, an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.