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NCT05128903 · ClinicalTrials.gov registry record · Phase 2
Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study
A Phase 2 study of Brain Tumor and Medulloblastoma, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT05128903 is a Phase 2 study of Brain Tumor and Medulloblastoma that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 22 participants, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05128903, a Phase 2 study of Brain Tumor and Medulloblastoma, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
QARIN 1 is a study of \[18F\]DPA-714 Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy. This TSPO PET, uses a radioactive tracer. An optional MRI (magnetic resonance imaging) will also be performed to monitor brain microstructure damages induced by neuroinflammation. Primary Objectives * Assessment of temporal and regional variability of uptake of translocator protein (TSPO) positron emission tomography (PET) tracer. * Regional variability will be assessed in medial temporal lobe, frontal lobe, and in white matter * Temporal variability will be assessed by scanning each subject four-times: at baseline (before or within 2 weeks of start of radiation therapy), before start of chemotherapy, at 1 year from the initiation of the radiation therapy, and at 1.5-2 years from the initiation of the radiation therapy * Correlation of radiation dose in specific brain regions with radiation induced neuroinflammation as measured by uptake of TSPO PET tracer. Exploratory Objectives * Assessment of radiation-induced brain microstructure injuries (RIBMI) in specific brain regions (medial temporal lobe, frontal lobe, and in white matter) using advanced magnetic resonance imaging (MRI) techniques. * Association of radiation dose with MRI measures of RIBMI in these specific brain regions. * Association of PET measures of RIN with MRI measures of RIBMI. * Association of PET measure of RIN and MRI measures of RIBMI in specific regions of interest (ROI) with specific domain of neuro-cognition. For example, to investigate whether PET measure of RIN and MRI measures of RIBMI in hippocampal ROI have strongest association with episodic memory; whether frontal lobe cortical ROI are associated with attention and executive function. * Association of a novel MRI based technique for assessment of RIN with TSPO PET. * Association of the PET and MRI measure of neuroinflammati
Conditions Studied
Interventions
- DRUG [18F]DPA714
Study Locations (1)
Tennessee
- St.Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-07-05 |
| Est. Completion | 2035-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05128903
The ClinicalTrials.gov registry entry for NCT05128903 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (92% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Brain Tumor appearing as the primary indexed condition, and to 1 intervention - of which [18F]DPA714 is the first listed.
NCT05128903 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05128903 about?
NCT05128903 is a clinical study titled "Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study". QARIN 1 is a study of \[18F\]DPA-714 Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy. This TSPO PET, uses a radioactive tracer. An optional MRI (magnetic resonance imaging) wi...
What is the current status of trial NCT05128903?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2022-07-05. Estimated completion is 2035-12-31.
What conditions does trial NCT05128903 study?
This clinical trial studies the following conditions: Brain Tumor, Medulloblastoma.
What interventions are being tested in trial NCT05128903?
The interventions under investigation include: [18F]DPA714 (DRUG).
Who is sponsoring clinical trial NCT05128903?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05128903 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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