Brain TumorNCT02071017
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor
An observational study of Brain Tumor, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Brain Tumor
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Dec 2014
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Who may be able to join
- We will inculude the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Who cannot join
- We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: Application of the Simultaneous PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor From Differential Diagnosis to Prediction of Prognosis
Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially presented with brain tumors, and predict the prognosis in the patients diagnosed with primary high graded astrocytoma or oligodendroglioma.
Read the detailed description
Materials and methods: Simultaneous MRI-PET (FDG) will be prospectively obtained in patients (n = 60) initially presented with brain tumors by using integrated MRI-PET (Biograph mMR, Siemens, Germany). We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies. We will use the imaging protocols including whole body MRI-PET and advanced brain tumor imaging (DWI, PWI and DCE). In addition, we will analyze the imaging parameters to see whether the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Expected results: We expect that whole body MRI-PET is useful for the differential diagnosis of primary and metastatic brain tumors, and the multiparametric information from DWI, PWI, DCE and PET can be used for the tumor grading and prognosis prediction of the primary brain malignancies.
- Conditions
- Brain Tumor
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Hong Choi, Seoul National University Hospital
- Investigators
- SeungHong Choi, MD, PhD, Principal investigator, Seoul National University Hospital(Radiology)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071017
- Sponsor's protocol ID
- D-1212-014-447
- Status last verified
- Feb 2014
- First submitted
- 21 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Simultaneous PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor From Differential Diagnosis to Prediction of Prognosis
- ClinicalTrials.gov ID
- NCT02071017
- Acronym / sponsor ID
- D-1212-014-447
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 25 Feb 2014 (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.
Background and purpose: In adult, the half of the CNS neoplasms are metastatic, and high grade astrocytomas and oligodendrogliomas are most frequent malignant tumors among the last half. Recently, integrated MRI-PET (Biograph mMR, Siemens, Germany) was introduced, and can provide simultaneous whole body MRI-PET imaging as well as brain-specific advanced imaging (e.g. DWI, PWI, and DCE). The purpose of the present study is to evaluate whether the simultaneous MRI-PET acquisition can improve the diagnostic yield for the patients initially presented with brain tumors, and predict the prognosis in the patients diagnosed with primary high graded astrocytoma or oligodendroglioma.
Detailed description
Materials and methods: Simultaneous MRI-PET (FDG) will be prospectively obtained in patients (n = 60) initially presented with brain tumors by using integrated MRI-PET (Biograph mMR, Siemens, Germany). We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies. We will use the imaging protocols including whole body MRI-PET and advanced brain tumor imaging (DWI, PWI and DCE). In addition, we will analyze the imaging parameters to see whether the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Expected results: We expect that whole body MRI-PET is useful for the differential diagnosis of primary and metastatic brain tumors, and the multiparametric information from DWI, PWI, DCE and PET can be used for the tumor grading and prognosis prediction of the primary brain malignancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Key inclusion criteria (1 listed)
- We will inculude the enrolled tumors are primary brain tumors or metastatic, and evaluate the tumor grading efficiency and prognosis prediction for the patients with high grade astrocytomas or oligodendrogliomas.
Key exclusion criteria (1 listed)
- We will exclude the patients suspected to have benign brain tumors such as meningioma and schwannoma on previous imaging studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor
Time frame: 2year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
SeungHong Choi, MD, PhD principal investigator
Seoul National University Hospital(Radiology)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Feb 2014. 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 South Korea. 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?
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?
PET (FDG)-MR Imaging for the Adult Patients Presented With Brain Tumor (time frame: 2year). 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 25 Feb 2014.