Registering Genomics and Imaging of Tumors (ReGIT)

Study Purpose

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.

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.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria. 1. Subject is between 18 and 89 years of age. 2. 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*. 3. Subject is treatment-naïve with the exception of previous biopsy for the above condition. 4. Subject is planning to undergo surgical resection and biopsy of their brain tumor. 5. Subject has sufficient tissue so that the study team is able to acquire at least 2 biopsy samples during resection. 6. Subject is able to read and write in English. 7. Subject is able to lay supine for up to 80 minutes. 8. Subject is able to hold still during MRI procedures. 9. Subject or their LAR has signed the consent form for participation in the study. Exclusion Criteria. 1. Subject has conditions that would preclude the completion of an MRI such as claustrophobia, pacemaker, metal objects in the body, and/or pregnancy. 2. Subject has serious unstable medical or mental illness. 3. Subject has insufficient tissue to acquire at least two biopsy samples during resection. 4. Subject has a medical contraindication to any element of the study procedures. 5. Subject or their LAR has not read and signed the informed consent form, or does not understand its contents. 6. Subject is pregnant.** 7. 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 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.

NCT05386043
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.

Lead Sponsor

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

Indiana University
Principal Investigator

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

Jason Parker, PhD
Principal Investigator Affiliation Indiana University
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.

Glioma
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Drug: - FET F-18

PET scan with FET prior to biopsy

Drug: - O-15 Radioisotope

PET scan with O-15 Water prior to biopsy

Procedure: - CT scan

CT scan prior to biopsy

Procedure: - MRI with gadolinium-based contrast

MRI prior to biopsy

Procedure: - Biopsy Collection

Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision

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.

Indiana University School of Medicine, Indianapolis 4259418, Indiana 4921868

Status

Recruiting

Address

Indiana University School of Medicine

Indianapolis 4259418, Indiana 4921868, 46202

Site Contact

Mahsa Servati, MS

[email protected]

317-278-3384

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