Brain recurrent glioblastoma multiform
Conditions
Interventions
1:whole body PET/CT scanning with 18F-FHBG
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet all inclusion criteria for ADV-TK gene therapy clinical trials, and the patients have decided to receive ADV-TK gene therapy; 2. Consent signed by the patients or legal guardian; 3. Aged 18 to 70 years; 4. The pathology had been confirmed as glioblastoma multiform by the tissue pathology diagnosis after previous operation; 5. Diagnosed recurrence or progression by clinical and radiological evidence according to the RANO criteria; 6. If the recurrent diagnosis of recurrent GBM cannot be concluded according to MRI, the MRS or PET scanning should be done to confirm the diagnosis; 7. KPS score=60 and Life expectancy =8 weeks; 8. Adequate hepatic, renal, and hematologic function; 9. Normal heart functions; 10. Good Follow-up compliance; 11. Women of childbearing age (15 to 49 years old) must undergo a pregnancy study within 7 days prior to initiation of this trial and the results are negative; male and female patients with fertility must agree to use contraceptive measures to ensure that they will not pregnant during the study period and within 3 months after discontinuation of treatment.
Exclusion criteria
Exclusion criteria: 1. The tumor is too large, and it is highly probable that cranial decompression surgery to rescue within 3 months; 2. Intracerebral drug or antibody therapy have been used within 4 weeks prior to the start of the treatment; 3. Active infections; 4. Allergic to antiviral drug treatment or nuclear magnetic enhancer; 5. Pregnant or lactating women; 6. Does not agree to use effective contraception during the treatment period and for the following 3 months; 7. There are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease stable or progression on MRI according to RANO criteria;The safety of this tracer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactNan Ji
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed