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

NCT03058198 | Unknown

• 1 other identifier: 81672476
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Keywords

Glioma; PET; EGFR vIII; Multimodal neuronavigation; Molecular pathology; PET-CT; Neuronavigation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Secondary Outcomes (3)

• The overall survival time of participants

  4 years

• The progression-free survival time of participants

  4 year

• The correlation between EGFRvIII mutation and prognosis of participants

  4 year

Study Arms (1)

High Grade Glioma

EXPERIMENTAL

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.

Diagnostic Test: 89Zr-ABT806 PET

Interventions

89Zr-ABT806 PET DIAGNOSTIC_TEST

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.

High Grade Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, 200040, China

RECRUITING

Related Publications (16)

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  PMID: 1557402 BACKGROUND

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  PMID: 2236070 BACKGROUND

• Yamazaki H, Fukui Y, Ueyama Y, Tamaoki N, Kawamoto T, Taniguchi S, Shibuya M. Amplification of the structurally and functionally altered epidermal growth factor receptor gene (c-erbB) in human brain tumors. Mol Cell Biol. 1988 Apr;8(4):1816-20. doi: 10.1128/mcb.8.4.1816-1820.1988.

  PMID: 3380099 BACKGROUND

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  PMID: 2834047 BACKGROUND

• Ekstrand AJ, Sugawa N, James CD, Collins VP. Amplified and rearranged epidermal growth factor receptor genes in human glioblastomas reveal deletions of sequences encoding portions of the N- and/or C-terminal tails. Proc Natl Acad Sci U S A. 1992 May 15;89(10):4309-13. doi: 10.1073/pnas.89.10.4309.

  PMID: 1584765 BACKGROUND

• Nagane M, Coufal F, Lin H, Bogler O, Cavenee WK, Huang HJ. A common mutant epidermal growth factor receptor confers enhanced tumorigenicity on human glioblastoma cells by increasing proliferation and reducing apoptosis. Cancer Res. 1996 Nov 1;56(21):5079-86.

  PMID: 8895767 BACKGROUND

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  PMID: 8845302 BACKGROUND

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  PMID: 8052651 BACKGROUND

• Pedersen MW, Tkach V, Pedersen N, Berezin V, Poulsen HS. Expression of a naturally occurring constitutively active variant of the epidermal growth factor receptor in mouse fibroblasts increases motility. Int J Cancer. 2004 Feb 20;108(5):643-53. doi: 10.1002/ijc.11566.

  PMID: 14696090 BACKGROUND

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  PMID: 15475464 BACKGROUND

• Lammering G, Valerie K, Lin PS, Hewit TH, Schmidt-Ullrich RK. Radiation-induced activation of a common variant of EGFR confers enhanced radioresistance. Radiother Oncol. 2004 Sep;72(3):267-73. doi: 10.1016/j.radonc.2004.07.004.

  PMID: 15450724 BACKGROUND

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MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Dongxiao Zhuang, Professor

CONTACT

+86-21-52888771; ernestzdx@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 20, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: February 20, 2017

Record last verified: 2017-02

Locations

CN (1)