Brain NeoplasmsPhase 2NCT00204295
Study on Amino Acid Uptake in Brain Tumors
A Phase 2 study testing O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET in people with Brain Neoplasms, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to determine the uptake of the amino acid O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission tomography. A comparison to MRI and histopathological samples is used. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with suspected primary brain tumors
- CT or MRI showing lesion of >= 2,5 cm
- Any age; parents informed consent in children available
- Karnofsky-Index >= 20 %
- Referral by Depts. of Neurology, Neuro-Oncology, Neurosurgery, or Pediatric Neurology at the UKM
- Biopsy and/or surgery planned
- Patient is able to lie during the PET scan for 50 minutes without moving • Patient must be able to give informed consent; signature must be present before the PET scan
Who cannot join
- Pregnancy or breast feeing
- Patients, who by psychiatric disease are not able to give informed consent
- Complete renal failure
- Inclusion to other studies according to § 23 of the German radiation protection law
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Nuclear Medicine, University Hospital Muenster
Münster, North Rhine-Westphalia, D-48149
About this study
Official title: Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)
The purpose of this study is to determine the uptake of the amino acid O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission tomography. A comparison to MRI and histopathological samples is used.
Read the detailed description
Radioactively labelled amino acids have been used for years to delineate primary brain tumors and for the early detection of tumor recurrence. Positron emission tomography studies indicate that the extent of amino acid uptake correlates to the true histological extent of gliomas. Recently a fluorine-18 labelled amino acid has been introduced (O-(2-[F-18]Fluorethyl)-L-tyrosin (FET)), which is suitable for routine use in brain tumor patients. There is evidence that this amino acid is transported into brain and brain tumors by the amino acid transport of the L-type. The cDNA of this L-transporter has recently been cloned and has been shown to be identical to the light chain of the 4F2-antigen (CD98), which has previously been described as marker of cell growth and proliferation.
The heavy chain of this heterodimer is known to modulate integrins which are thought to play a fundamental role in glioma invasion.
Besides the evaluation of the diagnostic capability of FET in brain tumors, a comparison of FET uptake in vivo and CD98 expression ex-vivo is performed with tissue slices as available after routine surgery in glioma patients.
- Conditions
- Brain Neoplasms
- Being tested
- O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET
- Keywords
- Brain neoplasms, Positron-Emission Tomography, Amino Acids, Magnetic Resonance Imaging
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PETDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological samples where available
CD98 staining where available
Secondary outcomes (1)
Clinical follow-up for at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Weckesser, MD, Principal investigator, Department of Nuclear Medicine, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204295
- Sponsor's protocol ID
- FET-HT-MS
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 14 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study on Brain Tumor Uptake of the Amino Acid O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET)
- ClinicalTrials.gov ID
- NCT00204295
- Acronym / sponsor ID
- FET-HT-MS
- Conditions
- Brain Neoplasms
- Keywords
- Brain neoplasms, Positron-Emission Tomography, Amino Acids, Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the uptake of the amino acid O-(2-[F-18]Fluorethyl)-L-tyrosin (FET) in human brain tumors using positron emission tomography. A comparison to MRI and histopathological samples is used.
Detailed description
Radioactively labelled amino acids have been used for years to delineate primary brain tumors and for the early detection of tumor recurrence. Positron emission tomography studies indicate that the extent of amino acid uptake correlates to the true histological extent of gliomas. Recently a fluorine-18 labelled amino acid has been introduced (O-(2-[F-18]Fluorethyl)-L-tyrosin (FET)), which is suitable for routine use in brain tumor patients. There is evidence that this amino acid is transported into brain and brain tumors by the amino acid transport of the L-type. The cDNA of this L-transporter has recently been cloned and has been shown to be identical to the light chain of the 4F2-antigen (CD98), which has previously been described as marker of cell growth and proliferation.
The heavy chain of this heterodimer is known to modulate integrins which are thought to play a fundamental role in glioma invasion.
Besides the evaluation of the diagnostic capability of FET in brain tumors, a comparison of FET uptake in vivo and CD98 expression ex-vivo is performed with tissue slices as available after routine surgery in glioma patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with suspected primary brain tumors
- CT or MRI showing lesion of >= 2,5 cm
- Any age; parents informed consent in children available
- Karnofsky-Index >= 20 %
- Referral by Depts. of Neurology, Neuro-Oncology, Neurosurgery, or Pediatric Neurology at the UKM
Key exclusion criteria (4 listed)
- Pregnancy or breast feeing
- Patients, who by psychiatric disease are not able to give informed consent
- Complete renal failure
- Inclusion to other studies according to § 23 of the German radiation protection law
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 |
|---|---|---|
| O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET | Drug | – |
Primary outcome
Histological samples where available
CD98 staining where available
1 secondary outcome
Clinical follow-up for at least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2006.
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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.
Matthias Weckesser, MD principal investigator
Department of Nuclear Medicine, University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing O-(2-[F-18]Fluorethyl)-L-Tyrosin (FET) - PET in people with Brain Neoplasms, run by University Hospital Muenster at 1 site in Germany.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Sep 2006. 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 Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Histological samples where available. The study lists 2 primary outcomes in all. 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 14 Sep 2006; AzTrials last refreshed its copy on 6 Nov 2026.