Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Patients Diagnosed With a Glioma

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07735819
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Minocycline 200mg/day — DRUG
    Minocycline 200mg orally daily to start within 14 days of the first \[18F\]FETrp PET/CT and taken until the second \[18F\]FETrp PET/CT obtained 25-44 days after the start of the Minocycline in Arm 3
  • [18F]FETrp PET/CT — DIAGNOSTIC_TEST
    \[18F\]FETrp PET/CT used in all three arms

Study Details

The goal of this clinical trial is to evaluate Positron emission tomography/computed tomography (PET/CT) imaging with the radiotracer 1-(2-\[18F\]fluoroethyl)-l-tryptophan (\[18F\]FETrp) in patients diagnosed with a glioma. This study has 3 aims: * to assess if the \[18F\]FETrp PET/CT can outperform Magnetic Resonance Imaging (MRI) by providing a better treatment target volume in newly diagnosed Stage 4 glioma patients * better differentiate tumor progression from radiation induced MRI changes in post treatment stage 4 gliomas * by giving a drug that can inhibit a pathway to allow objective assessment of treatment effects in low grade gliomas

Key Dates

First listed
Jul 30, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

Enrollment
61 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [18F]FETrp PET/CT in newly diagnosed grade 4 glioma prior to radiation
    Arm 1. \[18F\]FETrp PET prior to radiotherapy in newly diagnosed grade 4 glioblastoma to provide a better treatment target volume
  • Experimental: [18F]FETrp PET/CT in previously treated gliomas with post radiation progression
    Arm 2. \[18F\]FETrp PET to differentiate post-treatment glioma progression from radiation-induced MRI changes
  • Experimental: [18F]FETrp PET/CT pre and post Minocycline 200mg/day
    Arm 3. Minocycline orally 200mg/day administered between the first \[18F\]FETrp PET scan and the month follow up \[18F\]FETrp scan to determine if pharmacologic inhibition of the kynurenine pathway will reduce tumoral tryptophan metabolic rates in low-grade gliomas

Primary Outcome Measure

Difference Between Dice Similarity Coefficients (DSC) of Position Emission Tomography (PET) High K Tumor Volume and DSC of MRI-based Tumor Volume (d-PETk-MRI) in Arm 1 [ Time Frame: From the time of the pre-radiotherapy scans (Baseline) up to tumor progression or study completion, assessed at a maximum follow-up of 2 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Csaba Juhasz, M.D., Ph.D
1-800-527-6266

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Karmanos Cancer Institute· Detroit, MI

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