Brain TumorNCT02241668
Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) vs. Adv. Magnetic Resonance (MR) Techniques in Recurrent Glioma
A study testing PET Scan and 3'-Deoxy-3'-18f-Fluorothymidine in people with Brain Tumor, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if using a new imaging solution, 3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help doctors determine if your brain lesion is from the tumor returning or the effects of previous treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- PET Scan and 3'-Deoxy-3'-18f-Fluorothymidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jun 2015
- Phase
- Interventional
- 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
Who may be able to join
- Patient is >/= 18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
- Patient is a candidate for cerebral tumor resection due to an enhancing brain lesion, with history of previous pathologically proven primary brain tumor (WHO grade II-IV diffuse glioma)
- Patient had diffuse glioma (WHO grade 2 - 4) and as part of their treatment received radiation therapy and Temozolomide (a first-line chemotherapeutic agent).
- Patient will have subsequently developed an enhancing brain mass greater than 1cm in diameter, at least 6 months after finishing radiation therapy (to differentiate from the more acute treatment related effect of "pseudo-progression").
- As the predominate means of determining TRN versus recurrent glial tumor at MD Anderson, a brain tumor/ necrosis protocol is ordered as clinically indicated.
- Patient's clinician based on the clinical and MR information wants to proceed with biopsy or surgical resection within 30 days from when the brain tumor MR protocol was performed. The patient meets with the neurosurgeon and agrees to surgical biopsy or resection.
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- Patient is able to understand and give consent to participation in the study
- Patient has received as part of their care the Brain Tumor Imaging protocol.
- Patient agrees to undergo, prior to the procedure, FLT PET at CABI
Who cannot join
- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy/ resection could not be safely performed
- Claustrophobia that does not readily respond to oral medication
- Allergy to Fluoro-L-Thymidine
- Pregnant or lactating (Based on self-reported and clinical care testing with physicians before study participation)
About this study
Official title: Pilot Study to Assess Accuracy of Time-resolved FLT PET and MR Techniques in Determining Treatment-related Necrosis From Recurrent Glioma
The goal of this clinical research study is to learn if using a new imaging solution, 3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help doctors determine if your brain lesion is from the tumor returning or the effects of previous treatments.
The results of this imaging scan (called an FLT PET scan) will be compared to the results of a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have outside of this study.
Read the detailed description
FLT PET Scan:
If you are found to be eligible to take part in this study, you will have an FLT PET scan.
An FLT PET scan uses the 3'-Deoxy-3'-18f-Fluorothymidine solution, which contains a small amount of radioactive material. The radioactive nature of the solution allows the scanner to "see" it in certain places in your body. You will receive the solution by vein through a catheter. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for about 60 minutes. During the scan, you will lie flat on your back on a table. After the solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. By watching how the solution travels through the body and studying where the solution collects, researchers may be able to learn where the disease is in your body. The entire procedure should last about 60-70 minutes.
You must not eat or drink anything except water for at least 6 hours before the FLT PET scan.
About 2 minutes after the FLT solution is injected, blood (about 10 teaspoons) will be drawn from the catheter. This blood will be drawn to measure how much FLT is in your body and may help the study staff understand the images better.
Length of Study:
After the FLT PET scan is complete, your active participation on this study will be over.
Follow-Up Medical Record Review:
About 30 days after the FLT PET scan, you will be contacted by phone by the study staff to check if you are having any side effects. The phone call should last about 15 minutes.
Your medical records will continue to be reviewed for up to an additional 5 years to learn how you are doing, what other treatments you may have had and how they worked, if you had any new brain problems, or if the tumor came back.
This is an investigational study. The 3'-Deoxy-3'-18f-Fluorothymidine solution is not FDA approved or commercially available. At this time, 3'-Deoxy-3'-18f-Fluorothymidine solution is only being used in research.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Brain Tumor
- Being tested
- PET Scan, 3'-Deoxy-3'-18f-Fluorothymidine
- Keywords
- Brain tumor, 3'-Deoxy-3'-18f-Fluorothymidine, Fluoro-L-Thymidine Positron Emission Tomography, FLT PET, Magnetic resonance imaging, MRI
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScanProcedure or surgery
Also called Positron Emission Tomography
FLT Pet Scan performed about 60 minutes after 3'-Deoxy-3'-18f-Fluorothymidine solution injected.
3'-Deoxy-3'-18f-FluorothymidineDrug
3'-Deoxy-3'-18f-Fluorothymidine solution injected through a central venous catheter after MRI scan. After solution injected into a vein, PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. Entire procedure should last about 60-70 minutes.
| Study group | Role | What they receive |
|---|---|---|
| FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine | Experimental | After a magnetic resonance imaging (MRI) scan of brain performed, an FLT PET scan using 3'-Deoxy-3'-18f-Fluorothymidine solution performed. After solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. The entire procedure should last about 60-70 minutes. Receives: Procedure: PET Scan; Drug: 3'-Deoxy-3'-18f-Fluorothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) and Perfusion Magnetic Resonance Imaging (MRI) in the Diagnosis of Recurrent High-Grade Glial Tumor
Performance (sensitivity, specificity, negative/ positive predictive values) for MR perfusion and FLT PET made using prior reported values (PEI > 20% 10 and normalized uptake >1.3 17, respectively). Particular attention placed on the location for ROI's and pathology sampling in large heterogenous lesions. Additional, exploratory analysis performed to determine post-hoc optimal cut-off values for classifying glioma vs. necrosis. Logistic regression used to fit a model using a combination of a perfusion values, spectroscopy values, diffusion values, and values from FLT PET.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionJun 2015
Why it stopped: Withdrawn due to other initiatives
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 M.D. Anderson 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Eric Rohren, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241668
- Sponsor's protocol ID
- 2013-0283
- Status last verified
- Feb 2016
- First submitted
- 2 Sep 2014
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Accuracy of Time-resolved FLT PET and MR Techniques in Determining Treatment-related Necrosis From Recurrent Glioma
- ClinicalTrials.gov ID
- NCT02241668
- Acronym / sponsor ID
- 2013-0283
- Conditions
- Brain Tumor
- Keywords
- Brain tumor, 3'-Deoxy-3'-18f-Fluorothymidine, Fluoro-L-Thymidine Positron Emission Tomography, FLT PET, Magnetic resonance imaging, MRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to other initiatives
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- First posted
- 16 Sep 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.
The goal of this clinical research study is to learn if using a new imaging solution, 3'-Deoxy-3'-18f-Fluorothymidine, in a positron emission tomography (PET) scan can help doctors determine if your brain lesion is from the tumor returning or the effects of previous treatments.
The results of this imaging scan (called an FLT PET scan) will be compared to the results of a Magnetic Resonance Imaging scan, which you have already had or are scheduled to have outside of this study.
Detailed description
FLT PET Scan:
If you are found to be eligible to take part in this study, you will have an FLT PET scan.
An FLT PET scan uses the 3'-Deoxy-3'-18f-Fluorothymidine solution, which contains a small amount of radioactive material. The radioactive nature of the solution allows the scanner to "see" it in certain places in your body. You will receive the solution by vein through a catheter. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for about 60 minutes. During the scan, you will lie flat on your back on a table. After the solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. By watching how the solution travels through the body and studying where the solution collects, researchers may be able to learn where the disease is in your body. The entire procedure should last about 60-70 minutes.
You must not eat or drink anything except water for at least 6 hours before the FLT PET scan.
About 2 minutes after the FLT solution is injected, blood (about 10 teaspoons) will be drawn from the catheter. This blood will be drawn to measure how much FLT is in your body and may help the study staff understand the images better.
Length of Study:
After the FLT PET scan is complete, your active participation on this study will be over.
Follow-Up Medical Record Review:
About 30 days after the FLT PET scan, you will be contacted by phone by the study staff to check if you are having any side effects. The phone call should last about 15 minutes.
Your medical records will continue to be reviewed for up to an additional 5 years to learn how you are doing, what other treatments you may have had and how they worked, if you had any new brain problems, or if the tumor came back.
This is an investigational study. The 3'-Deoxy-3'-18f-Fluorothymidine solution is not FDA approved or commercially available. At this time, 3'-Deoxy-3'-18f-Fluorothymidine solution is only being used in research.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine | Experimental | Procedure: PET Scan, Drug: 3'-Deoxy-3'-18f-FluorothymidineAfter a magnetic resonance imaging (MRI) scan of brain performed, an FLT PET scan using 3'-Deoxy-3'-18f-Fluorothymidine solution performed. After solution is injected into a vein, the PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. The entire procedure should last about 60-70 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient is >/= 18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
- Patient is a candidate for cerebral tumor resection due to an enhancing brain lesion, with history of previous pathologically proven primary brain tumor (WHO grade II-IV diffuse glioma)
- Patient had diffuse glioma (WHO grade 2 - 4) and as part of their treatment received radiation therapy and Temozolomide (a first-line chemotherapeutic agent).
- Patient will have subsequently developed an enhancing brain mass greater than 1cm in diameter, at least 6 months after finishing radiation therapy (to differentiate from the more acute treatment related effect of "pseudo-progression").
- As the predominate means of determining TRN versus recurrent glial tumor at MD Anderson, a brain tumor/ necrosis protocol is ordered as clinically indicated.
Key exclusion criteria (4 listed)
- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy/ resection could not be safely performed
- Claustrophobia that does not readily respond to oral medication
- Allergy to Fluoro-L-Thymidine
- Pregnant or lactating (Based on self-reported and clinical care testing with physicians before study participation)
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 |
|---|---|---|
| PET ScanAlso: Positron Emission TomographyFLT Pet Scan performed about 60 minutes after 3'-Deoxy-3'-18f-Fluorothymidine solution injected. | Procedure or surgery | FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine |
| 3'-Deoxy-3'-18f-Fluorothymidine3'-Deoxy-3'-18f-Fluorothymidine solution injected through a central venous catheter after MRI scan. After solution injected into a vein, PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. Entire procedure should last about 60-70 minutes. | Drug | FLT PET Scan + 3'-Deoxy-3'-18f-Fluorothymidine |
Primary outcome
Performance of Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) and Perfusion Magnetic Resonance Imaging (MRI) in the Diagnosis of Recurrent High-Grade Glial Tumor
Time frame: 1 day
Performance (sensitivity, specificity, negative/ positive predictive values) for MR perfusion and FLT PET made using prior reported values (PEI > 20% 10 and normalized uptake >1.3 17, respectively). Particular attention placed on the location for ROI's and pathology sampling in large heterogenous lesions. Additional, exploratory analysis performed to determine post-hoc optimal cut-off values for classifying glioma vs. necrosis. Logistic regression used to fit a model using a combination of a perfusion values, spectroscopy values, diffusion values, and values from FLT PET.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Eric Rohren, MD, PHD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing PET Scan and 3'-Deoxy-3'-18f-Fluorothymidine in people with Brain Tumor, run by M.D. Anderson Cancer Center.
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 9 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: withdrawn, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Performance of Fluoro-L-Thymidine Positron Emission Tomography (FLT PET) and Perfusion Magnetic Resonance Imaging (MRI) in the Diagnosis of Recurrent High-Grade Glial Tumor (time frame: 1 day). 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 26 Feb 2016.