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ACTIVE NOT RECRUITING
NCT05128903
PHASE2

Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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 neuroinflammation within 2- years of completion of radiation with delayed cognitive outcome that will be measured at 3, 4 and 5 years from the completion of radiation

Key Details

Gender

All

Age Range

8 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2022-07-05

Completion Date

2035-12-31

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

[18F]DPA714

Intravenous injection * Before or within 2 weeks of starting radiation therapy * Before starting chemotherapy * 1 year after the start of radiation therapy Timing cont. * 1.5 to 2 years after the start of radiation therapy

Locations (1)

St.Jude Children's Research Hospital

Memphis, Tennessee, United States