GliomaReGITNCT05386043
Registering Genomics and Imaging of Tumors (ReGIT)
An observational study of Glioma, run by Indiana University at 1 site in United States.
Trial summary
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- FET F-18, O-15 Radioisotope and CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2023to 17 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.
Who may be able to join
- Subject is between 18 and 89 years of age.
- Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI*.
- Subject is treatment-naïve with the exception of previous biopsy for the above condition.
- Subject is planning to undergo surgical resection and biopsy of their brain tumor.
- Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
- Subject is able to read and write in English.
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- Subject is able to lay supine for up to 80 minutes.
- Subject is able to hold still during MRI procedures.
- Subject or their LAR has signed the consent form for participation in the study.
Who cannot join
- Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
- Subject has serious unstable medical or mental illness.
- Subject has insufficient tissue to acquire at least two biopsy samples during resection.
- Subject has a medical contraindication to any element of the study procedures.
- Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
- Subject is pregnant.**
- Subject is at high risk for NSF (eGFR<60 or serum creatine >1.3) and cannot follow the weight-based dosing protocol for Gadavist.***
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Mahsa Servati, MS, 317-278-3384, mservati@iu.edu
Jason Parker, PhD
About this study
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.
Read the detailed description
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.
- Conditions
- Glioma
- Being tested
- FET F-18, O-15 Radioisotope, CT scan, MRI with gadolinium-based contrast, Biopsy Collection
- Keywords
- glioma, glioblastoma
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FET F-18Drug
PET scan with FET prior to biopsy
O-15 RadioisotopeDrug
Also called O-15 Water
PET scan with O-15 Water prior to biopsy
CT scanProcedure or surgery
CT scan prior to biopsy
MRI with gadolinium-based contrastProcedure or surgery
MRI prior to biopsy
Biopsy CollectionProcedure or surgery
Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision
| Study group | Role | What they receive |
|---|---|---|
| Baseline Imaging and Biopsy | Subjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively. Receives: Drug: FET F-18; Drug: O-15 Radioisotope; Procedure: CT scan; Procedure: MRI with gadolinium-based contrast; Procedure: Biopsy Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification sensitivity
Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to >80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (>.95)
Measured: Through study completion, an average of 1 year.
Multivariate analysis
Statistically determine if MRI, and 15O-H2O and FET-PET (if available) independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences
Measured: 2032
Survival
Statistically determine if SMM classifications using MRI, and 15O-H2O and FET-PET (if available) can predict progression-free survival (PFS) and overall survival (OS), and individual voxel responses to chemotherapy and radiation therapy.
Measured: 2032
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 Jul 2023
- Primary completion17 Jul 2030 (estimated)
- Study completion17 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Jason Parker, Indiana University
- Investigators
- Jason Parker, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386043
- Sponsor's protocol ID
- 11163
- Acronym
- ReGIT
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registering Genomics and Imaging of Tumors (ReGIT)
- ClinicalTrials.gov ID
- NCT05386043
- Acronym / sponsor ID
- ReGIT / 11163
- Conditions
- Glioma
- Keywords
- glioma, glioblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 17 Jul 2030 (estimated)
- Study completion
- 17 Jul 2032 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations.
Detailed description
This study is investigating how brain tumors might mutate over time, and whether new brain imaging tools like MRI and PET can predict these mutations. Subjects who are radiologically diagnosed with gliomas and are expected to undergo a tumor biopsy will be enrolled in the study. Subjects will complete two visits and will then undergo a follow-up period. At the baseline visit, subjects will under go a pregnancy test (if applicable), two PET-CT scans using different radioactive tracers, an MRI scan, and blood draws. At the biopsy visit, the subject will undergo an MRI scan as part of their standard of care and at least biopsy samples will be collected for research purposes using stereotactic core biopsy. The study team will take pictures of the locations of tumor samples as they are removed during surgery. The samples then get studied for genetic mutations, and the study team will look at the parts of the image the samples came from to see if they could have been predicted. Follow-up MRIs and potentially other radiology scans will be completed as part of subjects' regular care on a schedule determined by their healthcare provider at the facility ordered by their physician. The study team will follow subjects' care and collect the information from their regularly scheduled treatments and brain scans after their biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline Imaging and Biopsy | – | Drug: FET F-18, Drug: O-15 Radioisotope, Procedure: CT scan, Procedure: MRI with gadolinium-based contrast, Procedure: Biopsy CollectionSubjects will receive a PET-CT with the radiopharmaceuticals FET and O-15 Water (under RDRC approval for basic research) prior to their standard of care neurosurgery via stereotactic core biopsy. Research samples will be collected for analysis intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our subject population will consist of a single-arm of human glioma patients (WHO grade II-IV) in an age range of 18-89 years. Patients will be recruited from the IU Health system of academic hospitals including Simon Cancer Center (an NCI-designated Comprehensive Cancer Center), Methodist Hospital, University Hospital, Neuroscience Center, North Hospital, and Saxony Hospital. The total recruitment target for this protocol is up to 20 glioma patients, or approximately 10 patients per year.
Key inclusion criteria (9 listed)
- Subject is between 18 and 89 years of age.
- Subject has radiologically-diagnosed or suspected WHO Grade II-IV glioma based on physician review or conformance with published WHO criteria as evaluated by the PI*.
- Subject is treatment-naïve with the exception of previous biopsy for the above condition.
- Subject is planning to undergo surgical resection and biopsy of their brain tumor.
- Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection.
Key exclusion criteria (7 listed)
- Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy.
- Subject has serious unstable medical or mental illness.
- Subject has insufficient tissue to acquire at least two biopsy samples during resection.
- Subject has a medical contraindication to any element of the study procedures.
- Subject or their LAR has not read and signed the informed consent form, or does not understand its contents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FET F-18PET scan with FET prior to biopsy | Drug | Baseline Imaging and Biopsy |
| O-15 RadioisotopeAlso: O-15 WaterPET scan with O-15 Water prior to biopsy | Drug | Baseline Imaging and Biopsy |
| CT scanCT scan prior to biopsy | Procedure or surgery | Baseline Imaging and Biopsy |
| MRI with gadolinium-based contrastMRI prior to biopsy | Procedure or surgery | Baseline Imaging and Biopsy |
| Biopsy CollectionBiopsy collection during standard of care neurosurgery for glioma diagnosis/excision | Procedure or surgery | Baseline Imaging and Biopsy |
Primary outcome
Classification sensitivity
Time frame: Through study completion, an average of 1 year.
Statistical evaluation of the area under the ROC curve. 3.1.1 SMM classification sensitivity to >80% 3.1.2 Reduce computation time by a factor of 10, and maintain accuracy (>.95)
Multivariate analysis
Time frame: 2032
Statistically determine if MRI, and 15O-H2O and FET-PET (if available) independently predict multiscale properties and together improve classification accuracy and sensitivity for SMM compared to 5 baseline MR sequences
Survival
Time frame: 2032
Statistically determine if SMM classifications using MRI, and 15O-H2O and FET-PET (if available) can predict progression-free survival (PFS) and overall survival (OS), and individual voxel responses to chemotherapy and radiation therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Parker, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Parker, PhD ((317) 274-2072, parkerjg@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification sensitivity (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.