Brain TumorPhase 2NCT05128903
Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study
A Phase 2 study testing [18F]DPA714 in people with Brain Tumor and Medulloblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 39 years
- Conditions the study is for
- Brain Tumor, Medulloblastoma
- What is being tested?
- [18F]DPA714
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 31 Dec 2035
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read more
- 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.
- Conditions
- Brain Tumor, Medulloblastoma
- Being tested
- [18F]DPA714
- Medical subject headings
- Brain Neoplasms, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]DPA714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVr
SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 1
Measured: follow up 1: up to 13 weeks after radiation therapy
SUVr
SUVr values for medial prefrontal cortex comparing baseline vs. follow up 1
Measured: follow up 1 : up to 13 weeks after radiation therapy
SUVr
SUVr values for hippocampus comparing baseline vs. follow up 1.
Measured: follow up 1 : up to 13 weeks after radiation therapy
SUVr
SUVr values for Corpus callosum comparing baseline vs. follow up 1.
Measured: follow up 1 : up to 13 weeks after radiation therapy
SUVr
SUVr values for corticospinal tract comparing baseline vs. follow up 1.
Measured: follow up 1 : up to 13 weeks after radiation therapy
SUVr
SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 1
Measured: follow up 1 : up to 13 weeks after radiation therapy
SUVr
SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for medial prefrontal cortex comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for hippocampus comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for Corpus callosum comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for corticospinal tract comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 2.
Measured: follow up 2: up to 53 weeks after radiation therapy
SUVr
SUVr values for dorsolateral prefrontal cortex comparing baseline vs. follow up 3.
Measured: follow up 3: up to 2 years after radiation therapy
SUVr
SUVr values for medial prefrontal cortex comparing baseline vs. follow up 3.
Measured: follow up 3: up to 2 years after radiation therapy
SUVr
SUVr values for hippocampus comparing baseline vs. follow up 3.
Measured: follow up 3: up to 2 years after radiation therapy
SUVr
SUVr values for Corpus callosum comparing baseline vs. follow up 3
Measured: follow up 3: up to 2 years after radiation therapy
SUVr
SUVr values for corticospinal tract comparing baseline vs. follow up 3.
Measured: follow up 3: up to 2 years after radiation therapy
SUVr
SUVr values for superior longitudinal fasciculus comparing baseline vs. follow up 3.
Measured: follow up 3: up to 2 years after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start5 Jul 2022
- Primary completion26 Oct 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asim Bag, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128903
- Sponsor's protocol ID
- QARIN1
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.