EpendymomaNCT01117155
A Pilot Study Evaluating 18F-L-Thymidine (FLT) PET Imaging in Children With Gliomas
An observational study of Ependymoma and Brainstem Glioma, run by National Cancer Institute (NCI).
Trial summary
Background: Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is difficult to tell if the scan is abnormal because of tumor size or shape, swelling, scar tissue, or dead tissue. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Ependymoma, Brainstem Glioma, Astrocytoma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2010to 22 Oct 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 1 year to less than 18 years of age
- Diagnosis: Patients must have a histologic diagnosis of a malignant glioma for which radiation therapy is prescribed. Patients with DIPG or optic pathway gliomas are exempt from this requirement and do not require a histologic diagnosis. All patients must have evaluable (not necessarily measurable) disease.
- Weight less than or equal to 70 kg (to limit radioisotope exposure to maximum adult dose)
- All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and risks of this study.
- Organ Function: Patients must have adequate organ function defined as:
- Hepatic: SGOT/AST, SGPT/ALT less than 5 times the ULN, Total bilirubin less than or equal to 2 times the ULN
Show all 10Show fewer
- Renal: Serum creatinine within the upper limit of normal values for age
- Serum Glucose: less than 150 mg/dL
- Female patients of childbearing potential must have a negative serum or urine pregnancy test
- Patients must be able to undergo both the FLT and FDG PET without the use of general anesthesia.
Who cannot join
- Patients unable to undergo MR imaging for any reason (including but not limited to the presence of a metallic implant that is not MRI compatible)
- Pregnant women are excluded because of known harmful effects of radiation on the fetus and the unknown effects of strong magnetic fields and Gadolinium contrast agents on the fetus.
- Any patient with a history of severe reaction (requiring medication) to Gd-DTPA, FDG or FLT.
- Any patient with permanent dental hardware, which, in the judgment of the Principal Investigator, would interfere with obtaining spectroscopy in the area of the tumor.
- Any patient who has begun an investigational agent within 48 hours prior to receiving (18)F-FLT.
About this study
Background:
- Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is difficult to tell if the scan is abnormal because of tumor size or shape, swelling, scar tissue, or dead tissue. Because brain tumor biopsies require surgery, researchers are looking for more noninvasive ways of evaluating brain tumors.
- Positron emission tomography (PET) scans use a radioactive sugar known as 18F-FDG to try to determine if a tumor is active or not. Active tumors generally take up more sugar than the surrounding tissue, but because normal brain tissue uses the same sugar as brain tumors, it is then difficult to tell if tumor tissue is taking up sugar or not. A different radioactive agent, 18F-FLT, is now being studied in some adults with different kinds of tumors. Researchers are interested in determining whether it is possible to use this agent as a marker of tumor activity in children.
Read more
Objectives:
- To determine the safety and effectiveness of 18F-FLT for pediatric glioma scans.
- To compare the results of 18F-FLT studies with studies using the radioactive agents 18F-FDG and 1H-MRSI.
Eligibility:
- Children less than 18 years of age who are having radiation therapy to treat malignant gliomas.
Design:
- Participants will have scanning tests before radiation therapy, 1 to 3 weeks after radiation therapy, and if researchers suspect that the tumor is growing.
- This study will involve three separate imaging tests (1H-MRSI, 18F-FDG PET, and 18F-FLT PET).
- Proton spectroscopy (1H-MRSI) is a procedure that is similar to MRI and is performed in the same scanner as an MRI. Because this scan is long (2-3 hours), most children will receive medications from an anesthesiologist so that they can sleep through the procedure.
- Within 2 weeks of the 1H-MRSI scan, participants will have the PET scans with both the standard contrast agent (18F-FDG) and the experimental agent (18F-FLT). These scans will last approximately 1 hour each.
Read the detailed description
BACKGROUND:
- A limitation of current investigational therapy for patients with brain tumors is assessment of response.
- (18)F-FDG PET is commonly used to assess tumor metabolism. However, normal brain uses glucose as an energy source, resulting in increased background FDG uptake, which confounds results and makes it difficult to distinguish normal from neoplastic activity.
- Newer imaging techniques that noninvasively assess metabolic and physiologic characteristics of brain tumor tissue are being developed to identify biomarkers of clinical efficacy in trials of new molecularly targeted agents.
- (18)F-fluorothymidine (FLT) is a PET radiopharmaceutical that is taken up by proliferating cells and may therefore serve as a surrogate marker of early response or lack of response to treatment.
- This study will prospectively evaluate (18)F-FLT in children undergoing radiation therapy for gliomas.
OBJECTIVES:
Primary objectives:
- Determine the feasibility of (18)F-FLT PET imaging in pediatric patients with malignant gliomas
- Determine the ability of (18)F-FLT PET imaging to detect treatment changes in pediatric patients with malignant gliomas undergoing radiation therapy
Secondary objectives:
- Determine the safety and toxicity profile of PET imaging using (18)F-FLT in pediatric patients with malignant gliomas
- To correlate changes in (18)F-FLT PET before and after radiation with outcome (12 month PFS)
- To compare the performance of (18)F-FLT-PET to that of MR perfusion, proton magnetic resonance spectroscopy (1H-MRSI) and (18)F-FDG PET in prediction of tumor response, time to progression and overall survival time.
ELIGIBILITY:
- Children less than 18 years of age with malignant gliomas for whom radiation therapy is prescribed.
- Adequate organ function defined as:
- Hepatic: SGOT, SGPT less than 5 times the ULN; total and direct bilirubin less than or equal to 2 times the ULN
- Renal: Serum creatinine must be within the upper limit of normal values
- Fasting serum glucose less than 150 mg/dL
- Negative serum or urine pregnancy test in females of childbearing potential
DESIGN:
-Patients will undergo MRI (with 1H-MRSI and perfusion), (18)F-FLT PET and (18)F-FDG PET within 2 weeks of each other at the following time points: pre-radiation therapy, 1-3 weeks post-radiation therapy, and at the time of suspected progression.
- Conditions
- Ependymoma, Brainstem Glioma, Astrocytoma, Glioblastoma Multiforme, PNET
- Keywords
- Brain Tumor, Imaging, FLT, FDG, Spectroscopy, Glioma, Glioblastoma Multiforme, Astrocytoma
- Medical subject headings
- Ependymoma, Astrocytoma, Glioblastoma, Neuroectodermal Tumors, Primitive, Brain Neoplasms, Glioma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start23 Apr 2010
- Study completion22 Oct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpendymomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Katherine E Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117155
- Sponsor's protocol ID
- 100105
- Other IDs
- 10-C-0105
- Status last verified
- 22 Oct 2012
- First submitted
- 4 May 2010
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Rekate HL, Rakfal SM. Low-grade astrocytomas of childhood. Neurol Clin. 1991 May;9(2):423-40.
PubMed 1944108Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
PubMed 10655437Gururangan S, Cavazos CM, Ashley D, Herndon JE 2nd, Bruggers CS, Moghrabi A, Scarcella DL, Watral M, Tourt-Uhlig S, Reardon D, Friedman HS. Phase II study of carboplatin in children with progressive low-grade gliomas. J Clin Oncol. 2002 Jul 1;20(13):2951-8. doi: 10.1200/JCO.2002.12.008.
PubMed 12089224
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating 18F-L-Thymidine (FLT) PET Imaging in Children With Gliomas
- ClinicalTrials.gov ID
- NCT01117155
- Acronym / sponsor ID
- 100105
- Conditions
- Ependymoma, Brainstem Glioma, Astrocytoma, Glioblastoma Multiforme, PNET
- Keywords
- Brain Tumor, Imaging, FLT, FDG, Spectroscopy, Glioma, Glioblastoma Multiforme, Astrocytoma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Apr 2010
- Study completion
- 22 Oct 2012
- First posted
- 5 May 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.
Background:
- Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is difficult to tell if the scan is abnormal because of tumor size or shape, swelling, scar tissue, or dead tissue. Because brain tumor biopsies require surgery, researchers are looking for more noninvasive ways of evaluating brain tumors.
- Positron emission tomography (PET) scans use a radioactive sugar known as 18F-FDG to try to determine if a tumor is active or not. Active tumors generally take up more sugar than the surrounding tissue, but because normal brain tissue uses the same sugar as brain tumors, it is then difficult to tell if tumor tissue is taking up sugar or not. A different radioactive agent, 18F-FLT, is now being studied in some adults with different kinds of tumors. Researchers are interested in determining whether it is possible to use this agent as a marker of tumor activity in children.
Objectives:
- To determine the safety and effectiveness of 18F-FLT for pediatric glioma scans.
- To compare the results of 18F-FLT studies with studies using the radioactive agents 18F-FDG and 1H-MRSI.
Eligibility:
- Children less than 18 years of age who are having radiation therapy to treat malignant gliomas.
Design:
- Participants will have scanning tests before radiation therapy, 1 to 3 weeks after radiation therapy, and if researchers suspect that the tumor is growing.
- This study will involve three separate imaging tests (1H-MRSI, 18F-FDG PET, and 18F-FLT PET).
- Proton spectroscopy (1H-MRSI) is a procedure that is similar to MRI and is performed in the same scanner as an MRI. Because this scan is long (2-3 hours), most children will receive medications from an anesthesiologist so that they can sleep through the procedure.
- Within 2 weeks of the 1H-MRSI scan, participants will have the PET scans with both the standard contrast agent (18F-FDG) and the experimental agent (18F-FLT). These scans will last approximately 1 hour each.
Detailed description
BACKGROUND:
- A limitation of current investigational therapy for patients with brain tumors is assessment of response.
- (18)F-FDG PET is commonly used to assess tumor metabolism. However, normal brain uses glucose as an energy source, resulting in increased background FDG uptake, which confounds results and makes it difficult to distinguish normal from neoplastic activity.
- Newer imaging techniques that noninvasively assess metabolic and physiologic characteristics of brain tumor tissue are being developed to identify biomarkers of clinical efficacy in trials of new molecularly targeted agents.
- (18)F-fluorothymidine (FLT) is a PET radiopharmaceutical that is taken up by proliferating cells and may therefore serve as a surrogate marker of early response or lack of response to treatment.
- This study will prospectively evaluate (18)F-FLT in children undergoing radiation therapy for gliomas.
OBJECTIVES:
Primary objectives:
- Determine the feasibility of (18)F-FLT PET imaging in pediatric patients with malignant gliomas
- Determine the ability of (18)F-FLT PET imaging to detect treatment changes in pediatric patients with malignant gliomas undergoing radiation therapy
Secondary objectives:
- Determine the safety and toxicity profile of PET imaging using (18)F-FLT in pediatric patients with malignant gliomas
- To correlate changes in (18)F-FLT PET before and after radiation with outcome (12 month PFS)
- To compare the performance of (18)F-FLT-PET to that of MR perfusion, proton magnetic resonance spectroscopy (1H-MRSI) and (18)F-FDG PET in prediction of tumor response, time to progression and overall survival time.
ELIGIBILITY:
- Children less than 18 years of age with malignant gliomas for whom radiation therapy is prescribed.
- Adequate organ function defined as:
- Hepatic: SGOT, SGPT less than 5 times the ULN; total and direct bilirubin less than or equal to 2 times the ULN
- Renal: Serum creatinine must be within the upper limit of normal values
- Fasting serum glucose less than 150 mg/dL
- Negative serum or urine pregnancy test in females of childbearing potential
DESIGN:
-Patients will undergo MRI (with 1H-MRSI and perfusion), (18)F-FLT PET and (18)F-FDG PET within 2 weeks of each other at the following time points: pre-radiation therapy, 1-3 weeks post-radiation therapy, and at the time of suspected progression.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age: 1 year to less than 18 years of age
- Diagnosis: Patients must have a histologic diagnosis of a malignant glioma for which radiation therapy is prescribed. Patients with DIPG or optic pathway gliomas are exempt from this requirement and do not require a histologic diagnosis. All patients must have evaluable (not necessarily measurable) disease.
- Weight less than or equal to 70 kg (to limit radioisotope exposure to maximum adult dose)
- All patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and risks of this study.
- Organ Function: Patients must have adequate organ function defined as:
Key exclusion criteria (5 listed)
- Patients unable to undergo MR imaging for any reason (including but not limited to the presence of a metallic implant that is not MRI compatible)
- Pregnant women are excluded because of known harmful effects of radiation on the fetus and the unknown effects of strong magnetic fields and Gadolinium contrast agents on the fetus.
- Any patient with a history of severe reaction (requiring medication) to Gd-DTPA, FDG or FLT.
- Any patient with permanent dental hardware, which, in the judgment of the Principal Investigator, would interfere with obtaining spectroscopy in the area of the tumor.
- Any patient who has begun an investigational agent within 48 hours prior to receiving (18)F-FLT.
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
Not reported in the source record.
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 12 Dec 2019.
- Background: PubMed 1944108Rekate HL, Rakfal SM. Low-grade astrocytomas of childhood. Neurol Clin. 1991 May;9(2):423-40.
- Background: PubMed 10655437Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.
- Background: PubMed 12089224Gururangan S, Cavazos CM, Ashley D, Herndon JE 2nd, Bruggers CS, Moghrabi A, Scarcella DL, Watral M, Tourt-Uhlig S, Reardon D, Friedman HS. Phase II study of carboplatin in children with progressive low-grade gliomas. J Clin Oncol. 2002 Jul 1;20(13):2951-8. doi: 10.1200/JCO.2002.12.008.
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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.
Katherine E Warren, M.D. principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Ependymoma and Brainstem Glioma, run by National Cancer Institute (NCI).
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 10 inclusion and 5 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 12 Dec 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117155, which also lists 3 linked publications.
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 12 Dec 2019.