Malignant Tumors Clinical Trial
Official title:
Safety and Clinical Value of 18Fluorine-labeled BBPA PET/CT in Patients With Malignant Tumors
Verified date | March 2024 |
Source | Peking Union Medical College Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is an open-labeled phase II diagnostic clinical trial to explore the safety and clinical value of BBPA-PET/CT in suspected malignant tumor patients. The investigation regarding the clinical value of BBPA concerning the metabolic characteristics of BBPA in suspected malignant tumors. Quantitative features will be extracted to analysis the PET images. For patient who took surgery after multiple examination, histopathology, molecular pathology and LAT-1 immunohistochemistry will also be obtained.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have suspected diagnosis of brain tumors, based on clinical performance and imaging results. - Meet the indications for PET examination, show a clear indication and no contraindications; - Have a performance status of score =80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; - Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; - Be = 18 years of age on day of signing informed consent. - Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: - Have a history of imaging agent allergies; - Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination; - Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; - Unable to adhere strictly to protocol requirements. |
Country | Name | City | State |
---|---|---|---|
China | Wenbin Ma | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Peking University, Peking University Cancer Hospital & Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | standardized uptake value (SUV) for BBPA | SUV reflects the uptake of PET tracers, and quantitative imaging features such as SUVmax, SUVmean, and visually assessed features will be measured in the evaluation of tumors. | 1 week | |
Secondary | Adverse events | Adverse event within 1 week after BBPA injection will be documented. | 1 week |
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