High Grade GliomaNCT01240161
Personalized Translational Platform for Biomarker Discovery in Brain Tumors
An observational study of High Grade Glioma, run by Marcelo F. Di Carli, MD, FACC at 2 sites in United States.
Trial summary
The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Grade Glioma
- What is being tested?
- FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Mar 2016
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/ neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high grade gliomas) will be consented and enrolled in this study after adequate explanation of the risks and benefits of the study.
Who may be able to join
- Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT
- Anticipated survival ≥6 months
- Able to give informed consent
- Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia
- Male or Female
Who cannot join
- Prior radiation therapy and chemotherapy to the brain
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month)
- Expected survival <6 months
- Pregnant or nursing
- Renal failure
- Lives far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of California at San Diego
San Diego, California, 92093
About this study
The central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.
- Conditions
- High Grade Glioma
- Being tested
- FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT
- Keywords
- Glioblastoma multiforme, FLT, PET
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CTDrug
Each patient will have 0-3 or more FLT-PET brain scans.
| Study group | Role | What they receive |
|---|---|---|
| Patients with high grade gliomas | All subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients. Receives: Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 7 months
Progression free Survival
MRI and clinical criteria
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo F. Di Carli, MD, FACC
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Nuclear Medicine and Molecular Imaging, General Electric
- Responsible party
- Sponsor-investigator, Marcelo F. Di Carli, MD, FACC, Brigham and Women's Hospital
- Investigators
- Marie Kijewski, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240161
- Sponsor's protocol ID
- 2008P000554
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2010
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Translational Platform for Biomarker Discovery in Brain Tumors
- ClinicalTrials.gov ID
- NCT01240161
- Acronym / sponsor ID
- 2008P000554
- Conditions
- High Grade Glioma
- Keywords
- Glioblastoma multiforme, FLT, PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Marcelo F. Di Carli, MD, FACCUniversity, hospital or other
- Collaborators
- Society of Nuclear Medicine and Molecular Imaging, General Electric
- Study start
- Dec 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Nov 2010 (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 central hypothesis for this proposal is that multimodal (clinical, imaging, tissue) biomarkers will better predict early brain tumor response to treatments and will be more reliable prognostic markers in patients with malignant brain tumors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with high grade gliomas | – | Drug: FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CTAll subjects will have radiographically suspected or surgically proven de novo high grade gliomas. There are no control patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to BWH/DFCI emergency department (ED), inpatient, or neurology/ neurosurgery/ radiation oncology clinics with newly diagnosed brain masses (suspected high grade gliomas) will be consented and enrolled in this study after adequate explanation of the risks and benefits of the study.
Key inclusion criteria (5 listed)
- Newly diagnosed or suspected high grade glioma ≥ 1cm in diameter on postoperative anatomic imaging (contrast MRI), prior to initiation of chemoXRT
- Anticipated survival ≥6 months
- Able to give informed consent
- Capable of undergoing MRI and PET scans without the need for sedation or general anesthesia
- Male or Female
Key exclusion criteria (7 listed)
- Prior radiation therapy and chemotherapy to the brain
- Active intracranial infection or nonglial brain mass.
- Recent large intracranial hemorrhage (<1 month)
- Expected survival <6 months
- Pregnant or nursing
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 |
|---|---|---|
| FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CTEach patient will have 0-3 or more FLT-PET brain scans. | Drug | Patients with high grade gliomas |
Primary outcome
Overall Survival
Time frame: 7 months
Progression free Survival
Time frame: 7 months
MRI and clinical criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
Diffuse Glioma, Malignant Glioma
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Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
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A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
Malignant Glioma
RecruitingPhase 1
Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas
Currently Only Enrolling Glioblastoma Patients at First Recurrence
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.
Marie Kijewski, PhD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Grade Glioma, run by Marcelo F. Di Carli, MD, FACC at 2 sites 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 5 inclusion and 7 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 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Survival (time frame: 7 months). 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 29 Aug 2017.