About this trial
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in glioblastoma patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent and HIPAA authorization obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
Histologically confirmed diagnosis of glioblastoma
Resection surgery done at the study center (Henan Provincial People's Hospital), with an reservoir intraoperatively implanted connecting the surgical cavity and the subscalp for postoperative noninvasive TISF collection
Disqualifiers
Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring chronic and systemic immunosuppressive treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects have any other condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalent are permitted in absence of active autoimmune disease
Clinically significant (i.e., active) cardiovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment. Any previous venous thromboembolism ≥ NCI CTCAE Grade 3 within 3 months prior to start of study treatment
Trial population
adult patients with glioblastoma
Trial design
Case-only
Prospective
Treatments tested in this trial
Observational only
Other interventionThis is an observational study
Treatment groups
Trial outcomes
Primary outcomes
Functional and genomic profiling of glioblastoma
Prognostic stratification will be evaluated using following parameters: Quantitative and qualitative parameters from CT, PET, MRI Genomic data of glioblastoma tumor samples and tumor in situ fluid samples
Secondary outcomes
Relationship between genomic and multiparametric imaging profiling
We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of glioblastoma.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: