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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 8 Years - 39 Years
Gender All
More Inclusion & Exclusion Criteria

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:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05128903
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St. Jude Children's Research Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Asim Bag, MD
Principal Investigator Affiliation St. Jude Children's Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Tumor, Medulloblastoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

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.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St.Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

St.Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Asim Bag, MD

[email protected]

866-278-5833

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