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

Primary Purpose

Glioma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
89Zr-ABT806 PET
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring Glioma, PET, EGFR vIII, Multimodal neuronavigation, Molecular pathology, PET-CT, Neuronavigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Huashan hospital, Fudan universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Grade Glioma

Arm Description

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.

Outcomes

Primary Outcome Measures

The sensitivity and specificity of 89Zr-ABT806 PET
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

The overall survival time of participants
regular follow-up
The progression-free survival time of participants
regular follow-up
The correlation between EGFRvIII mutation and prognosis of participants

Full Information

First Posted
February 11, 2017
Last Updated
February 15, 2017
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03058198
Brief Title
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
Glioma, PET, EGFR vIII, Multimodal neuronavigation, Molecular pathology, PET-CT, Neuronavigation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Grade Glioma
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
89Zr-ABT806 PET
Intervention Description
Patients will be given IV bolus injection of 89Zr-ABT806(1-2mCi). The first 89Zr-ABT806 PET scan will be performed about 72 to 120 hours after injection of tracer. The second 89Zr-ABT806 PET scan will be performed about 120 to 168 hours after injection of tracer. Semi-quantitative analysis was performed using the maximum standardized uptake value (SUVmax) and T/N ratio.
Primary Outcome Measure Information:
Title
The sensitivity and specificity of 89Zr-ABT806 PET
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The overall survival time of participants
Description
regular follow-up
Time Frame
4 years
Title
The progression-free survival time of participants
Description
regular follow-up
Time Frame
4 year
Title
The correlation between EGFRvIII mutation and prognosis of participants
Time Frame
4 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical manifestations and imaging examination (CT, MRI, et al) are in accordance with high grade glioma No PET/CT scanning contraindications No MRI scanning contraindications Patients older than 18 years old ECOG score between 0 to 2 Patients with sufficient bone marrow, kidney and liver function reserve. All patients gave written informed consent. Exclusion Criteria: Patient who has received immune therapy, radiation therapy, chemotherapy, hormone drugs, biological products or other clinical trials within 14 days. Patient who has received EGFR monoclonal antibody therapy within 4 weeks. Patients who has not fully recovered form the past drug toxicity reaction (CTCAE in grade 2 or above). Patient who has received major surgery within 7 days. Patients with allergies to immunoglobulin. Breastfeeding women. pregnant women Patients with severe clinical condition. Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongxiao Zhuang, Professor
Phone
+86-21-52888771
Email
ernestzdx@163.com
Facility Information:
Facility Name
Huashan hospital, Fudan university
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangfu Zhou, Professor
Phone
+86-21-52887200
Email
lfzhouc@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Nijiati Kudulaiti, M.D.
First Name & Middle Initial & Last Name & Degree
Dongxiao Zhuang, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Zhemin Huang, M.D.
First Name & Middle Initial & Last Name & Degree
Chengjun Yao, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Tainming Qiu, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Junfeng Lu, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Huiwei Zhang, M.D.
First Name & Middle Initial & Last Name & Degree
Zhengwei Zhang, M.D.
First Name & Middle Initial & Last Name & Degree
Yihui Guan, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Jingsong Wu, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Zhifeng Shi, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Jie Zhang, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Fangyuan Gong, M.D.
First Name & Middle Initial & Last Name & Degree
Zhengda Yv, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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