Clinical trial · Observational
Registering Genomics and Imaging of Tumors (ReGIT)
NCT05386043CI-TRIAL-00095113ReGITrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Collection | Procedure | — | UNRESOLVED |
| CT scan | Procedure | — | UNRESOLVED |
| FET F-18 | Drug | — | UNRESOLVED |
| MRI with gadolinium-based contrast | Procedure | — | UNRESOLVED |
| O-15 Radioisotope | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Baseline Imaging and Biopsy
- description
- 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.
- interventionNames
- Drug: FET F-18
- Drug: O-15 Radioisotope
- Procedure: CT scan
- Procedure: MRI with gadolinium-based contrast
- Procedure: Biopsy Collection
Primary outcomes (3)
- measure
- Classification sensitivity
- timeFrame
- Through study completion, an average of 1 year.
- description
- 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)
- measure
- Multivariate analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.\*\*\*
References
Publications (0)
Data not yet available
No reference posted for this study.