Status:
UNKNOWN
Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Tumor, Solid
Positron-Emission Tomography
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
To evaluate the normal physiological distribution of positron nuclide labeled DOTA-FAPI PET/CT in human body and its diagnostic efficiency for colorectal cancers
Detailed Description
Participants first undergo an 18F-FDG PET/CT, followed by 68Ga-FAPI04 PET/CT in groups. The purpose of the study is to explore the possibility of superiority of FAPI in diagnosis of colorectal cancer ...
Eligibility Criteria
Inclusion
- ECOG score 0-2
- patients with newly diagnosed or previously treated colorectal cancers
- patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT for tumor staging to decide the most proper treatment strategy
- patients who underwent paired 18F-FDG and 68Ga-FAPI PET/CT to detect tumor recurrence and metastases (repeat staging)
- 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;
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04750772
Start Date
October 16 2019
End Date
January 1 2023
Last Update
June 27 2022
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142