The Research on 89Zr-ABT806 PET Imaging in High Grade Glioma

Not Applicable

• Conditions: Glioma
• Interventions: Diagnostic Test: 89Zr-ABT806 PET

• Registration Number: NCT03058198
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Study First Posted: 2017-02-20
• Last Update Posted: 2017-02-20
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Grade Glioma	89Zr-ABT806 PET	We plan to perform PET scanning on the patients with high grade gliomas after the injection of the second generation of EGFR tracer ,89Zr-ABT806（1-2mCi）, which can be specifically binded to EGFR vⅢ . After fusing the PET and MRI images, we precisely obtained the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status was detected by Sanger sequencing to analyze the correlation with the 89Zr-ABT806 PET image qualitatively and quantitatively. The final goal was to detect EGFR vⅢ by noninvasive molecular imaging procedure for the clinical outcome prediction and the selection of EGFR-targeted therapies.

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of 89Zr-ABT806 PET	4 years	After fusing the 89Zr-ABT806 PET and MRI images, investigators precisely obtained the tissue from the"hot-spot" on the PET image through multimodal-neuronavigation-guided tumor biopsy. EGFRvⅢ status will be analyzed by molecular methods. The sensitivity and specificity of 89Zr-ABT806 PET will be measured with statistic methods.

Secondary Outcome Measures

Name	Time	Method
The overall survival time of participants	4 years	regular follow-up
The progression-free survival time of participants	4 year	regular follow-up
The correlation between EGFRvIII mutation and prognosis of participants	4 year

Trial Locations

Locations (1)

Huashan hospital, Fudan university; 🇨🇳 Shanghai, China