Registering Genomics and Imaging of Tumors (ReGIT)

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05386043
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FET F-18 — DRUG
    PET scan with FET prior to biopsy
  • O-15 Radioisotope — DRUG
    PET scan with O-15 Water prior to biopsy
  • CT scan — PROCEDURE
    CT scan prior to biopsy
  • MRI with gadolinium-based contrast — PROCEDURE
    MRI prior to biopsy
  • Biopsy Collection — PROCEDURE
    Biopsy collection during standard of care neurosurgery for glioma diagnosis/excision

Study 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.

Key Dates

Start date
Jul 18, 2023
Status verified
Sep 2025
Primary completion
Jul 17, 2030
Completion
Jul 17, 2032

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Classification sensitivity [ Time Frame: Through study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University School of MedicineIndianapolisIndiana46202
Mahsa Servati, MS
[email protected]
317-278-3384
Jason Parker, PhD (PRINCIPAL_INVESTIGATOR)

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By specialty
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By research site
Indiana University School of Medicine· Indianapolis, IN

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