A Phase 2 interventional study of [18F] FLT in Brain Neoplasms, sponsored by Frederick Daniel Grant. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Frederick Daniel Grant · Phase 2, Interventional, and Diagnostic
Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)
Although pediatric central nervous system tumors are rare, they are a significant contributor to morbidity and mortality in children. Tumor staging, detecting recurrent tumor, and assessing the response to therapy are critical in the treatment of brain tumors, but current imaging methods have major limitations in providing such information. The objective of this study is to validate 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) as a measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging agent in children with central nervous system tumors. The proposed studies will evaluate 18F-FLT PET in three groups:
In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for accurate identification of tumor recurrence, and for early assessment of the response to chemotherapy.
1,959 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.
This study's enrollment of 50 is above the median of 40 across 1,457 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →This is the only study on the registry with Frederick Daniel Grant as lead sponsor.
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Exclusion Criteria:
In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using \[18F\] FLT.
Drug: [18F] FLT
In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using \[18F\] PET.
Drug: [18F] FLT
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.
Drug: [18F] FLT
\[18F\] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
Also known as: 3'-deoxy-3'-[F-18] fluorothymidine, [18F] fluorothymidine
[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
\[18F\] 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.
Time frame: on average 1 week
MIB Positive (Percent)
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining
Time frame: 30 days
Biodistribution of [18F]FLT
The distribution, localization, and kinetics of localization of \[18F\] FLT will be assessed by FLT-PET in 12 subjects.
Time frame: 6 hours
Preliminary Evaluation of Clinical Utility of [18F] FLT PET
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.
Time frame: 3 months
Potential participants were identified by clinicians participating in their care.
| Milestone | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy |
|---|---|---|---|
| Started | 16 | 28 | 6 |
| Successful completion of flt-pet | 14 | 26 | 5 |
| Surgery within 30 days of flt-pet | 13 | 8 | 0 |
| Surgical pathology demonstrated evaluable brain tumor | 11 | 7 | 0 |
| Mib immunohistology available | 8 | 5 | 0 |
| Completed | 8 | 5 | 0 |
| Not completed | 8 | 23 | 6 |
| Withdrew: Physician decision | 2 | 18 | 5 |
| Withdrew: Radiopharmaceutical flt (18f-fluorothymidine) unavailable to perform pet scan before surgery | 1 | 1 | 0 |
| Withdrew: Surgical pathology did not confirm evaluable brain tumor | 2 | 1 | 0 |
| Withdrew: Mib immunopathology results not available | 3 | 2 | 0 |
| Withdrew: Pet data failure | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
\[18F\] 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.
| SUV max | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor |
|---|---|---|
| [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation | 1.57 (0.12 to 4.00) | 3.00 (1.54 to 4.00) |
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining
| percent positive cells | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor |
|---|---|---|
| MIB Positive (Percent) | 17.3 (0.9 to 59.4) | 32.8 (4.3 to 89) |
The distribution, localization, and kinetics of localization of \[18F\] FLT will be assessed by FLT-PET in 12 subjects.
No measurements were reported for this outcome.
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.
| SUV max | Brain Tumor Response to Chemotherapy |
|---|---|
| FLT uptake pre-therapy | 0.85 (0 to 1.53) |
| FLT uptake post-therapy | 0.47 (0 to 1.13) |
Collected over 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| New Diagnosis of Brain Tumor | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Possible Recurrent Brain Tumor | 0/28 (0%) | 2/28 (7.1%) | 3/28 (10.7%) |
| Brain Tumor Response to Chemotherapy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy |
|---|---|---|---|
| intracranial tumor hemorrhageNervous system disorders | 0/16 | 1/28 | 0/6 |
| reversible posterior leukoencephalopathy sydromeNervous system disorders | 0/16 | 1/28 | 0/6 |
| Event | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy |
|---|---|---|---|
| anemiaBlood and lymphatic system disorders | 0/16 | 2/28 | 0/6 |
| urticarial rashSkin and subcutaneous tissue disorders | 1/16 | 0/28 | 0/6 |
| lymphopeniaBlood and lymphatic system disorders | 0/16 | 1/28 | 0/6 |
| Age, Categorical(Participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| <=18 years | 16 | 27 | 6 | 49 |
| Between 18 and 65 years | 0 | 1 | 0 | 1 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| Female | 1 | 15 | 1 | 17 |
| Male | 13 | 11 | 4 | 28 |
| Other/ Not recorded | 2 | 2 | 1 | 5 |
| Ethnicity (NIH/OMB)(Participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 6 | 1 | 9 |
| Not Hispanic or Latino | 12 | 19 | 4 | 35 |
| Unknown or Not Reported | 2 | 3 | 1 | 6 |
| Race (NIH/OMB)(Participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 3 | 3 | 2 | 8 |
| White | 9 | 16 | 3 | 28 |
| More than one race | 2 | 3 | 0 | 5 |
| Unknown or Not Reported | 2 | 2 | 0 | 4 |
| Region of Enrollment(participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| United States | 16 | 28 | 6 | 50 |
| Brain Tumor classification(Participants) | New Diagnosis of Brain Tumor | Possible Recurrent Brain Tumor | Brain Tumor Response to Chemotherapy | Total |
|---|---|---|---|---|
| Gliomas, Glioneuronal, and Neuronal Tumors | 11 | 18 | 5 | 34 |
| Embryonal Tumors (including former PNET) | 1 | 7 | 1 | 9 |
| Pineal Tumors | 1 | 0 | 0 | 1 |
| Germ Cell Tumors (Teratoma) | 0 | 1 | 0 | 1 |
| Hematolymphoid Tumors (Lymphoma) | 1 | 0 | 0 | 1 |
| Non-neoplastic Process/No Diagnosis | 2 | 2 | 0 | 4 |
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Plan to share: No — No current plans to share individual participant data
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