GlioblastomaNCT01880008
Evaluation of FLT PET and MRI as Imaging Biomarkers of Early Treatment Response in Patients With Glioblastoma
An observational study of Glioblastoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- Type of treatment
- Injection or infusion
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with WHO grade III or IV glioma
Who may be able to join
- Adult patients (> 18 yo) with a pathological diagnosis of malignant glioma (WHO grades III and IV, including all histological subtypes)
- Surgical intervention includes subtotal resection or biopsy with MRI evidence of residual disease after resection
- Patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide
- Preoperative Karnofsky performance score (KPS) of > 60
- Willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include PET studies.
Who cannot join
- Patient refuses adjunctive therapy
- Pregnancy
- Karnofsky scale < 60
- Inability to undergo MR imaging studies
- Estimated GFR ≤ 60 ml/min (using GFR = 0.85*[140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for women and GFR = [140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for men).
- Inability or unwillingness to follow instructions for both PET and MR imaging sessions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: An Exploratory Study of Quantitative [18F]FLT-PET and Advanced MRI as Early Indicators of Treatment Response and Molecular Markers for Cell Proliferation in Patients With Glioblastoma Following Subtotal Resection
Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. In this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. The study examines how PET and MR imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. The investigators hypothesize that decreases in uptake of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia MR imaging that may also correlate well with treatment response.
Read the detailed description
Patients with glioblastoma will be imaged with FLT PET/CT followed by MRI. The FLT uptake will be correlated with advanced MRI markers of tumor progression to determine the ability of using FLT PET and MRI for predicting response to treatment.
- Conditions
- Glioblastoma
- Keywords
- positron emission tomography, magnetic resonance imaging, diffusion magnetic resonance imaging, radionuclide imaging, disease management, radiation therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | All patients included in this study were treated with temozolomide and radiotherapy after subtotal resection of a WHO grade III or IV glioma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter
Determines the change in FLT uptake as a result of chemotherapy/radiation therapy
Measured: Before and after chemotherapy/radiation therapy
Secondary outcomes (5)
Survival
Number of months from date of diagnosis to date of death.
Measured: 2 years
Ki-67
Ki-67 proliferation index on tumor specimens obtained at biopsy or from surgical resection specimen
Measured: At diagnosis
Radiographic progression defined by MacDonald criteria
MacDonald criteria to be used to determine whether tumor progress or not during the course of this study
Measured: 2 years
O(6)-methylguanine DNA-methyltransferase (MGMT) activity
MGMT activity from tumor specimens
Measured: prior to treatment
Time to progression
Months after completing radiation treatment to first instance of radiographic progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startApr 2008
- Primary completionFeb 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Responsible party
- Principal investigator, Delphine L. Chen, MD, Washington University School of Medicine
- Investigators
- Delphine L Chen, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880008
- Sponsor's protocol ID
- 08-0073
- Status last verified
- Jun 2013
- First submitted
- 30 Jul 2010
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Quantitative [18F]FLT-PET and Advanced MRI as Early Indicators of Treatment Response and Molecular Markers for Cell Proliferation in Patients With Glioblastoma Following Subtotal Resection
- ClinicalTrials.gov ID
- NCT01880008
- Acronym / sponsor ID
- 08-0073
- Conditions
- Glioblastoma
- Keywords
- positron emission tomography, magnetic resonance imaging, diffusion magnetic resonance imaging, radionuclide imaging, disease management, radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Barnes-Jewish Hospital
- Study start
- Apr 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Jun 2013 (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.
Glioblastoma is the most common primary malignant neoplasm of the adult brain. Even after multimodal therapy, outcomes remain poor, with a median survival of one year. Although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. In this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. The study examines how PET and MR imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. The investigators hypothesize that decreases in uptake of an investigational 18F-FLT PET tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. In a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia MR imaging that may also correlate well with treatment response.
Detailed description
Patients with glioblastoma will be imaged with FLT PET/CT followed by MRI. The FLT uptake will be correlated with advanced MRI markers of tumor progression to determine the ability of using FLT PET and MRI for predicting response to treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | –All patients included in this study were treated with temozolomide and radiotherapy after subtotal resection of a WHO grade III or IV glioma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with WHO grade III or IV glioma
Key inclusion criteria (5 listed)
- Adult patients (> 18 yo) with a pathological diagnosis of malignant glioma (WHO grades III and IV, including all histological subtypes)
- Surgical intervention includes subtotal resection or biopsy with MRI evidence of residual disease after resection
- Patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide
- Preoperative Karnofsky performance score (KPS) of > 60
- Willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include PET studies.
Key exclusion criteria (6 listed)
- Patient refuses adjunctive therapy
- Pregnancy
- Karnofsky scale < 60
- Inability to undergo MR imaging studies
- Estimated GFR ≤ 60 ml/min (using GFR = 0.85*[140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for women and GFR = [140 - age(y)]*[bodyweight(kg)]/[72*Cr(mg/dl)] for men).
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
Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter
Time frame: Before and after chemotherapy/radiation therapy
Determines the change in FLT uptake as a result of chemotherapy/radiation therapy
5 secondary outcomes
Survival
Time frame: 2 years
Ki-67
Time frame: At diagnosis
Radiographic progression defined by MacDonald criteria
Time frame: 2 years
O(6)-methylguanine DNA-methyltransferase (MGMT) activity
Time frame: prior to treatment
Time to progression
Time frame: 2 years
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 18 Jun 2013.
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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.
Delphine L Chen, MD principal investigator
Washington University School of Medicine
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 Glioblastoma, run by Washington University School of Medicine 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 5 inclusion and 6 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 18 Jun 2013. 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?
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?
Change in FLT uptake, measured by SUV tumor/SUV normal contralateral white matter (time frame: Before and after chemotherapy/radiation therapy). 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 18 Jun 2013.