Trial Outcomes & Findings for FLT-PET Imaging of Brain Tumors in Children (NCT NCT01244737)

Last Updated: 2024-07-11

Results Overview

\[18F\] FLT uptake, as determined by pre-operative positron emission tomography (PET) imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

on average 1 week

Results posted on

2024-07-11

Participant Flow

Potential participants were identified by clinicians participating in their care.

Participants were assigned to one of three arms, depending on clinical presentation: 1) Clinical concern for new brain tumor, 2) Clinical concern for recurrent brain tumor, or 3) Planned initiation of new chemotherapy for a known brain tumor

Participant milestones

Participant milestones
Measure	New Diagnosis of Brain Tumor In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Overall Study STARTED	16	28	6
Overall Study Successful Completion of FLT-PET	14	26	5
Overall Study Surgery Within 30 Days of FLT-PET	13	8	0
Overall Study Surgical Pathology Demonstrated Evaluable Brain Tumor	11	7	0
Overall Study MIB Immunohistology Available	8	5	0
Overall Study COMPLETED	8	5	0
Overall Study NOT COMPLETED	8	23	6

Reasons for withdrawal

Reasons for withdrawal
Measure	New Diagnosis of Brain Tumor In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Overall Study Physician Decision	2	18	5
Overall Study Radiopharmaceutical FLT (18F-fluorothymidine) unavailable to perform PET scan before surgery	1	1	0
Overall Study Surgical pathology did not confirm evaluable brain tumor	2	1	0
Overall Study MIB immunopathology results not available	3	2	0
Overall Study PET data failure	0	1	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

FLT-PET Imaging of Brain Tumors in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	New Diagnosis of Brain Tumor n=16 Participants In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 milliCurie (mCi)/kg once before a PET scan	Possible Recurrent Brain Tumor n=28 Participants In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy n=6 Participants In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=93 Participants	27 Participants n=4 Participants	6 Participants n=27 Participants	49 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex/Gender, Customized Female	1 Participants n=93 Participants	15 Participants n=4 Participants	1 Participants n=27 Participants	17 Participants n=483 Participants
Sex/Gender, Customized Male	13 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	28 Participants n=483 Participants
Sex/Gender, Customized Other/ Not recorded	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	6 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=93 Participants	19 Participants n=4 Participants	4 Participants n=27 Participants	35 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	8 Participants n=483 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	16 Participants n=4 Participants	3 Participants n=27 Participants	28 Participants n=483 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	4 Participants n=483 Participants
Region of Enrollment United States	16 participants n=93 Participants	28 participants n=4 Participants	6 participants n=27 Participants	50 participants n=483 Participants
Brain Tumor classification Gliomas, Glioneuronal, and Neuronal Tumors	11 Participants n=93 Participants	18 Participants n=4 Participants	5 Participants n=27 Participants	34 Participants n=483 Participants
Brain Tumor classification Embryonal Tumors (including former PNET)	1 Participants n=93 Participants	7 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants
Brain Tumor classification Pineal Tumors	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Brain Tumor classification Germ Cell Tumors (Teratoma)	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Brain Tumor classification Hematolymphoid Tumors (Lymphoma)	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Brain Tumor classification Non-neoplastic Process/No Diagnosis	2 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	4 Participants n=483 Participants

PRIMARY outcome

Timeframe: on average 1 week

Population: Participants were evaluable if brain tumor surgery was performed within 30 days of the FLT-PET scan, if surgical pathology confirmed the diagnosis of brain tumor, and the results of tissue immunohistology were available. On the brain PET scan, tumor uptake of FLT was assessed by SUVmax, the standard clinical measure of tracer uptake, and tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

Outcome measures

Outcome measures
Measure	New Diagnosis of Brain Tumor n=8 Participants In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor n=5 Participants In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation	1.57 SUV max Interval 0.12 to 4.0	3.00 SUV max Interval 1.54 to 4.0	—

PRIMARY outcome

Timeframe: 30 days

Population: Participants in Arm 3 (Brain tumor response to chemotherapy) were not expected to undergo surgery during their chemotherapy. Therefore, they did have FLT-PET, but no assessment for tumor proliferation (percent MIB positive) was performed.

On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

Outcome measures

Outcome measures
Measure	New Diagnosis of Brain Tumor n=8 Participants In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor n=5 Participants In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
MIB Positive (Percent)	17.3 percent positive cells Interval 0.9 to 59.4	32.8 percent positive cells Interval 4.3 to 89.0	—

SECONDARY outcome

Timeframe: 6 hours

Population: Saved PET scan data has not been retrievable or usable due to 1) storage/format incompatibility among PET cameras from different vendors, 2) lack of interoperablity among different generations of cameras from the same vendor, and 3) backup data in institutional radiology archiving systems is not universally available for retrieval for quantitative image analysis. To date, working with camera vendors and software developers has been unsuccessful in overcoming this problem.

The distribution, localization, and kinetics of localization of \[18F\] FLT will be assessed by FLT-PET in 12 subjects.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low and participant completion of the entire protocol was low. As it seemed unlikely that meaningful enrollment would be accomplished, a revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. Due to the small number of participants completing the protocol, FLT uptake was assessed, but clinical outcome was not evaluated.

In individuals with a diagnosed primary brain tumor in whom therapy will include chemotherapy,.\[18F\] FLT uptake, as determined by positron emission tomography (PET) imaging, will assessed before and after two cycles of chemotherapy. Response will be determined by comparing the FL uptake before and after therapy.

Outcome measures

Outcome measures
Measure	New Diagnosis of Brain Tumor n=6 Participants In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Preliminary Evaluation of Clinical Utility of [18F] FLT PET FLT uptake post-therapy	0.47 SUV max Interval 0.0 to 1.13	—	—
Preliminary Evaluation of Clinical Utility of [18F] FLT PET FLT uptake pre-therapy	0.85 SUV max Interval 0.0 to 1.53	—	—

Adverse Events

New Diagnosis of Brain Tumor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Possible Recurrent Brain Tumor

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Brain Tumor Response to Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	New Diagnosis of Brain Tumor n=16 participants at risk In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor n=28 participants at risk In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy n=6 participants at risk In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Nervous system disorders intracranial tumor hemorrhage	0.00% 0/16 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	3.6% 1/28 • Number of events 1 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/6 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.
Nervous system disorders reversible posterior leukoencephalopathy sydrome	0.00% 0/16 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	3.6% 1/28 • Number of events 1 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/6 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.

Other adverse events

Other adverse events
Measure	New Diagnosis of Brain Tumor n=16 participants at risk In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Possible Recurrent Brain Tumor n=28 participants at risk In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Brain Tumor Response to Chemotherapy n=6 participants at risk In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using \[18F\] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. \[18F\] FLT: \[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Skin and subcutaneous tissue disorders urticarial rash	6.2% 1/16 • Number of events 1 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/28 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/6 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.
Blood and lymphatic system disorders anemia	0.00% 0/16 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	7.1% 2/28 • Number of events 2 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/6 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.
Blood and lymphatic system disorders lymphopenia	0.00% 0/16 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	3.6% 1/28 • Number of events 1 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.	0.00% 0/6 • 1 week Systemic: Complete blood count and renal/liver labs before and after each FLT-PET. One week after FLT-PET, medical record review for adverse events. Non-systemic: Referring clinicians inform study team of severe adverse events. Review: Adverse events reported to the Institutional Review Board (IRB) using current institutional procedures. Two severe adverse events reviewed by the IRB were judged to be consistent with the underlying brain tumor and associated therapy, and not due to FLT-PET.

Additional Information

Dr. Frederick Grant

Children's Hospital of Philadelphia

Phone: 267-600-1542

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place