NCT05128903

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
117mo left

Started Jul 2022

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jul 2022Dec 2035

First Submitted

Initial submission to the registry

November 5, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2035

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

13.3 years

First QC Date

November 5, 2021

Last Update Submit

April 23, 2026

Conditions

Brain TumorMedulloblastoma

Outcome Measures

Primary Outcomes (18)

  • SUVr

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

    follow up 1: up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 1 : up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 1 : up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 1 : up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 1 : up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 1 : up to 13 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 2: up to 53 weeks after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

  • SUVr

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

    follow up 3: up to 2 years after radiation therapy

Study Arms (1)

Participants

EXPERIMENTAL

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

[18F]DPA714DRUG

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

Participants

Eligibility Criteria

Age8 Years - 39 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St.Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsMedulloblastoma

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeuroectodermal Tumors, PrimitiveNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Asim Bag, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2021

First Posted

November 22, 2021

Study Start

July 5, 2022

Primary Completion (Estimated)

October 26, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available at the time of article publication.
Access Criteria
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US(1)