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Active, not recruitingNCT05128903Updated Apr 24, 2026

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

A Phase 2 interventional study of [18F]DPA714 in Brain Tumor and Medulloblastoma, sponsored by St. Jude Children's Research Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
8 Years to 39 Years
Sex
All
01

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
Read the detailed description

The participant will have 4 PET scans using a novel PET tracer that will help the investigators to quantify when and where in brain neuroinflammation happens following radiation therapy. The participant will receive the first PET scan either before your first dose of radiation therapy or within 2 weeks of the start of radiation therapy. The second PET scan will be obtained before starting chemotherapy. The third scan will be after 1 year of treatment.The final scan will be 1 and a half to 2 years after the start of treatment.The scan process will begin an hour or so after the participant has been given tracer by injection. The entire PET scan process lasts about 2 hours.

02

Conditions studied

  • Brain Tumor
  • Medulloblastoma
03

In context

Brain Neoplasms

1,959 studies on the registry are indexed under Brain Neoplasms; 515 are open to participants now.

This study's planned enrollment of 22 is below the median of 40 across 1,457 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant is at least 8 years of age
  • Participants with histologically confirmed medulloblastoma and are scheduled to receive 36 Gy craniospinal irradiation
  • Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
  • Subjects have either have high-affinity or mixed-affinity TSPO binding sites as determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.

Exclusion criteria

Exclusion Criteria:

  • Participants with a large pseudomeningocele (>4 cm in size) at the surgical site, complications from ventricular access (evidenced by hemorrhage and/or enhancement along the catheter), large subdural effusion in the supra-tentorial compartment (>1 cm in the maximum transverse dimension). All of these are expected to induce inflammation.
  • Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
  • Subjects with low-affinity TSPO binding sites as determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.
  • Pregnant subjects.
  • Patients needing sedation for the PET scans or optional MRI scans.
  • Participants with a diagnosis of recurrent medulloblastoma.
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Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Participants

    Participants who meet the eligibility criteria in the study will receive Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy.

    Drug: [18F]DPA714

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

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What researchers measure

Primary outcomes

  1. SUVr

    SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 1

    Time frame: follow up 1: up to 13 weeks after radiation therapy

  2. SUVr

    SUVr values for medial prefrontal cortex comparing baseline vs. follow up 1

    Time frame: follow up 1 : up to 13 weeks after radiation therapy

  3. SUVr

    SUVr values for hippocampus comparing baseline vs. follow up 1.

    Time frame: follow up 1 : up to 13 weeks after radiation therapy

  4. SUVr

    SUVr values for Corpus callosum comparing baseline vs. follow up 1.

    Time frame: follow up 1 : up to 13 weeks after radiation therapy

  5. SUVr

    SUVr values for corticospinal tract comparing baseline vs. follow up 1.

    Time frame: follow up 1 : up to 13 weeks after radiation therapy

  6. SUVr

    SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 1

    Time frame: follow up 1 : up to 13 weeks after radiation therapy

  7. SUVr

    SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  8. SUVr

    SUVr values for medial prefrontal cortex comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  9. SUVr

    SUVr values for hippocampus comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  10. SUVr

    SUVr values for Corpus callosum comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  11. SUVr

    SUVr values for corticospinal tract comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  12. SUVr

    SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 2.

    Time frame: follow up 2: up to 53 weeks after radiation therapy

  13. SUVr

    SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 3.

    Time frame: follow up 3: up to 2 years after radiation therapy

  14. SUVr

    SUVr values for medial prefrontal cortex comparing baseline vs. follow up 3.

    Time frame: follow up 3: up to 2 years after radiation therapy

  15. SUVr

    SUVr values for hippocampus comparing baseline vs. follow up 3.

    Time frame: follow up 3: up to 2 years after radiation therapy

  16. SUVr

    SUVr values for Corpus callosum comparing baseline vs. follow up 3

    Time frame: follow up 3: up to 2 years after radiation therapy

  17. SUVr

    SUVr values for corticospinal tract comparing baseline vs. follow up 3.

    Time frame: follow up 3: up to 2 years after radiation therapy

  18. SUVr

    SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 3.

    Time frame: follow up 3: up to 2 years after radiation therapy

07

Study locations

1 site
  • St.Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05128903
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Jul 5, 2022
Primary completion
Oct 26, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Apr 24, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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