NCT05128903

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

Active, enrolled Phase 2 Last updated 15 December 2025

What this trial tests

Phase 2 trial testing [18F]DPA714 in Brain Tumor in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 July 2022

Primary endpoint
26 October 2035

31 December 2035

Quick facts

Lead sponsor	St. Jude Children's Research Hospital
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	22
Start date	5 July 2022
Primary completion	26 October 2035
Estimated completion	31 December 2035
Sites	1 location across United States

Drugs / interventions tested

• [18F]DPA714 — full drug profile →

Conditions studied

• Brain Tumor — all drugs for Brain Tumor →
• Medulloblastoma — all drugs for Medulloblastoma →

Sponsor

St. Jude Children's Research Hospital

Who can join

Adults 8 to 39, any sex, with Brain Tumor or Medulloblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
   van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155