MedTrace Logo

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

NCT05128903 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-04-24

No results posted yet for this 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 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

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Asim Bag, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-05
Primary Completion
2035-10-26
Completion
2035-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128903 on ClinicalTrials.gov