Recurrent Malignant brain tumors, including gliomas and brain metastases recurrent, brain tumor, glioma, brain metastasis
Conditions
Interventions
In patients with suspected recurrence of malignant brain tumors, [18]F-fluciclovine PET imaging is performed in addition to conventional MRI.
Positron-Emission Tomography
Sponsors
Narita Yoshitaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent to participate in the study has been obtained voluntarily. 2. The individual is 18 years of age or older at the time of consent. 3. The patient has been histologically diagnosed with a malignant brain tumor such as glioma or metastatic brain tumor. 4. Recurrence or radiation necrosis is suspected after radiotherapy, and written consent for tumor resection or biopsy has been obtained from the patient. 5. Gadolinium-enhanced MRI can be performed. 6. Laboratory tests performed within 30 days prior to obtaining consent meet the following organ function criteria: - T-Bil is 3.0 mg/dL or less - ALT and AST are 120 U/L or less - eGFR is 30 mL/min/1.73 square meter or more 7. No restrictions regarding performance status (PS), medical history, or other factors.
Exclusion criteria
Exclusion criteria: 1. The subject is pregnant, breastfeeding, or may be pregnant. 2. The principal investigator or sub-investigator determines that the subject is not eligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The positive predictive value of [18]F-fluciclovine PET imaging for resected specimens from malignant brain tumors, including gliomas and metastatic brain tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, presence or absence of adverse events associated with [18]F-fluciclovine PET imaging, negative predictive value, visual assessment by image readers, tumor-to-normal tissue ratio (T/N ratio), sensitivity, specificity, volume of gadolinium-enhancing areas, and volume of [18]F-fluciclovine uptake regions | — |
Contacts
Public ContactDaisuke Kawauchi
National Cancer Center Hospital
Outcome results
None listed