Lymphoma Clinical Trial
Official title:
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - ECOG score 0 or 1 - subjects with lymphoma or suspected tumor subjects who have recently (within 2 months) planned to receive pathological biopsy or tumor surgery - expected survival =12 weeks - blood routine, liver and kidney function meet the following criteria: blood routine: WBC=4.0×109L or neutrophils =1.5×109L, PLT=100×109/L, Hb=90g/L;PT and APTT ULN 1.5 or less;Liver and kidney function: t-bil =1.5×ULT(upper limit of normal value), ALT/AST=2.5ULN or =5×ULT(subjects with liver metastasis), ALP=2.5ULN(ALP= 4.5ULN if there is bone metastasis or liver metastasis);BUN 1.5 x or less ULT, SCr 1.5 x or less ULT - at least one measurable target lesion according to RECIST1.1 - women must use effective contraception during the study period and for 6 months after the end of the study (effective contraception means sterilization, hormone devices, condoms, contraceptives/pills, abstinence or vasectomy by a partner, etc.);Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period - able to understand and sign the informed consent voluntarily, with good compliance. Exclusion Criteria: - severe abnormalities of liver and kidney function; - women preparing for pregnancy, pregnancy and lactation; - cannot lie supine for half an hour; - refuse to join the clinical researcher; - suffering from claustrophobia or other mental illness; - conditions that other researchers considered inappropriate for the study. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SUV | Standardized uptake value of 68Ga/ 18f-nota-fapi04 for target lesion of subject or suspected tumor in each time point window (SUV) | 60 days | |
Secondary | SUVR | the ratio of the standardized uptake value(SUVR) of 68Ga/ 18f-nota-fapi04 for the target lesion or suspected tumor lesion within each time window to that of the normal tissue corresponding to the tumor lesion or suspected tumor lesion to the standardized uptake value of 68Ga/ 18f-nota-fapi04 | 60 days |
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