Clinical trial NCT03058198: The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma
Official title: The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma and Its Correlation to EGFRvIII
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glioma
Keywords: Glioma
PET
EGFR vIII
Multimodal neuronavigation
Molecular pathology
PET-CT
Neuronavigation
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The epidermal growth factor receptor variant Ⅲ(EGFR vⅢ) is commonly detected in high-grade gliomas, which is also an important epitope in EGFR-targeted therapies and correlated to poor prognosis. However, detection of this mutant usually needs resected tumor samples. For biopsy samples, test results may not represent the EGFR vⅢ status of the whole tumor tissues because of the heterogeneity of tumor. It is also not applicable for patients who are not suitable for surgical procedure due to the tumor location or patients' general conditions. Because of the importance of the epidermal growth factor receptor (EGFR) signal pathway in oncogenesis, maintenance, and progression of high grade glioma, there has been an intense effort to develop noninvasive molecular imaging approach for the selection and monitoring of EGFR-targeted therapies.

Based on investigators' previous study, investigators plan to perform PET scanning on the participants with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, investigators precisely obtain the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be detected by molecular methods to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. Investigators' final goal is to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.


Eligibility criteria: Inclusion Criteria:

1. Clinical manifestations and imaging examination (CT, MRI, et al) are in accordance with high grade glioma
2. No PET/CT scanning contraindications
3. No MRI scanning contraindications
4. Patients older than 18 years old
5. ECOG score between 0 to 2
6. Patients with sufficient bone marrow, kidney and liver function reserve.
7. All patients gave written informed consent.

Exclusion Criteria:

1. Patient who has received immune therapy, radiation therapy, chemotherapy, hormone drugs, biological products or other clinical trials within 14 days.
2. Patient who has received EGFR monoclonal antibody therapy within 4 weeks.
3. Patients who has not fully recovered form the past drug toxicity reaction (CTCAE in grade 2 or above).
4. Patient who has received major surgery within 7 days.
5. Patients with allergies to immunoglobulin.
6. Breastfeeding women.
7. pregnant women
8. Patients with severe clinical condition.
9. Inability to give informed consent

Primary outcomes:
measure: The sensitivity and specificity of 89Zr-ABT806 PET
timeFrame: 4 years
Secondary outcomes:
measure: The overall survival time of participants
timeFrame: 4 years
measure: The progression-free survival time of participants
timeFrame: 4 year
measure: The correlation between EGFRvIII mutation and prognosis of participants
timeFrame: 4 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital, Fudan university
Study officials:
References:
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