Status:
UNKNOWN
Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Tumor, Solid
Positron-Emission Tomography
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To evaluate the normal physiological distribution of positron nuclide labeled NOTA-F API in human body and its detection efficiency for lymphoma
Detailed Description
Subjects first undergo an 18F-FDG test, followed by 68Ga-NOTA-FAPI04 or 18F-NOTA-FAPI04 test in groups.Investigate the standardized uptake value(SUV) of 68Ga/ 18F-NOTA-FAPI04 for the target lesion, th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04367948
Start Date
May 1 2020
End Date
December 1 2022
Last Update
April 29 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142