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

Официальное название

Tryptophan-kynurenine Pathway PET Imaging in Human Gliomas

Обзор

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

Вмешательства

• Препарат Minocycline 200mg/day
  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
• Диагностический тест [18F]FETrp PET/CT
  \[18F\]FETrp PET/CT used in all three arms

Первичные конечные точки

• 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 [Срок оценки: 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.]
• Sensitivity of [18F]FETrp PET Kinetic Influx Rate (PETk) with a predefined L/C ratio threshold of 1.60 in differentiating Tumor Progression from Radiation Injury in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Change in [18F]FETrp Kinetic Influx Rate (K) Values Following One Month of Standard of Care Plus Indoleamine 2,3-dioxygenase (IDO) Inhibitor Treatment (d-PETK) in Arm 3 [Срок оценки: From Baseline (within 2 weeks prior to treatment initiation) to 1-month post-treatment (30 days ± 5 days, up to 44 days).]

Вторичные конечные точки (8)

• Difference Between Dice Similarity Coefficients (DSC) of PET High Standardized Uptake Value (SUV) Tumor Volume and DSC of MRI-based Tumor Volume (d-PETsuv-MRI) in Arm 1 [Срок оценки: 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.]
• Hazard Ratio for Progression-Free Survival Based on Pre-Radiotherapy (T1) [18F]FETrp PET High K Tumor Volume (PETk-T1) in Arm 1 [Срок оценки: From date of initial diagnosis up to first documented RANO 2.0 disease progression, death, or study closure, assessed up to a maximum of 2 years.]
• Specificity of [18F]FETrp PET Kinetic Influx Rate (PETk) with a predefined L/C ratio threshold of 1.60 in differentiating Tumor Progression from Radiation Injury in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Positive Predictive Value (PPV) of [18F]FETrp PET K L/C Ratio for Glioblastoma Progression in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Negative Predictive Value (NPV) of [18F]FETrp PET K L/C Ratio for Glioblastoma Progression in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Overall Diagnostic Accuracy of [18F]FETrp PET K L/C Ratio for Differentiating Tumor Progression From Radiation Injury in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Partial Area Under the Receiver Operating Characteristic Curve (pAUC) for [18F]FETrp PET K L/C Ratios in Arm 2 [Срок оценки: From the date of the [18F]FETrp PET/CT scan up to the date of confirmed ground truth designation via histopathology or serial MRI follow-up, assessed over a maximum period of 1 year per participant.]
• Change in [18F]FETrp PET Kinetic Influx Rate (K) Lesion-to-Contralateral (L/C) Ratios Following One Month of Standard of Care Plus IDO Inhibitor Treatment in Arm 3 [Срок оценки: From Baseline (within 2 weeks prior to treatment initiation) to 1-month post-treatment (30 days ± 5 days, up to 44 days).]

Критерии участия

FOR ARMS 1-3

Критерии включения

• Age =18 years.
• Patient is able to lie in the PET/CT scanner for at least 60 minutes while undergoing scanning.
• Patient is willing and able to review, understand, and provide written consent for the study procedures and indicates that they are aware of the investigational nature of this study.

Критерии исключения

• Patients who are pregnant or lactating are excluded. Premenopausal women (defined per institutional guidelines) must have a negative pregnancy test (urine or serum) within 7 days of the PET scan.
• Severe increased intracranial pressure, status epilepticus, or other severe or progressing clinical symptoms requiring urgent intervention in the opinion of the treating
• Karnofsky performance score <60, as determined by one of the clinician co- investigators.

ADDITIONAL CRITERIA FOR ARM 1:

Критерии включения

• Histopathology/cytopathological diagnosis of a glioblastoma without a history of radiation.
• The tumor is deemed amenable for radiation treatment (pre-radiation planning MRI can be done before or after the PET scan).

ADDITIONAL CRITERIA FOR ARM 2:

Критерии включения

• Previous histopathology/cytopathological diagnosis of glioblastoma.
• History of glioma radiation.
• Presence of a new or progressing enhancing brain lesion on follow-up clinical MRI suspicious for post-radiation glioma progression or late radiation-induced MRI changes (i.e., radiation injury), at least 7 mm in bidirectional diameter.
• The most recent MRI, used for comparison with the PET/CT, is performed within 4 weeks of the planned PET scan.

ADDITIONAL CRITERIA FOR ARM 3

Критерии включения

• MRI diagnosis of a brain tumor, previously verified to be a low-grade (WHO grade 2, IDH (isocitrate dehydrogenase) mutant glioma, based on histopathology from biopsy or resection.
• The detected mass on the most recent clinical MRI is at least 7 mm in bidirectional diameter (i.e., twice the PET scanner resolution).
• The tumor does not require urgent (within 1 month) resection, steroid treatment, or radiation.
• The most recent MRI, used for comparison with the PET/CT, is performed within 4 weeks.
• Patient agrees to have a baseline and follow-up PET/CT scan (approximately 1 month later) and interval oral treatment with 200mg/day minocycline.
• Due to planned minocycline treatment, patients will need to have adequate renal function

Критерии исключения

• Active connective tissue disorders, such as lupus or scleroderma.
• History of allergic reaction to minocycline or any tetracyclines.
• Ongoing treatment with warfarin with INR > 1.5.
• History of colitis during antibiotics treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Karmanos Cancer Institute — Detroit

Идентификаторы

NCT: NCT07735819 · 2026-055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗