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The research of PET imaging with positron nuclide radio-labeled FAPI in solid tumors

The research of PET imaging with positron nuclide radio-labeled FAPI in solid tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038080
Enrollment
Unknown
Registered
2020-09-09
Start date
2020-09-08
Completion date
Unknown
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

case series:Nil

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-75, male and female, with ECOG score of 0 or 1; 2) Subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months); 3) The expected survival was more than 12 weeks; 4) Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5uln; liver and kidney function: T-Bil <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5uln or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5uln (if bone metastasis or liver metastasis exists, ALP <= 4.5uln); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT; 5) According to RECIST1.1, there was at least one measurable target lesion; 6) Women must take effective contraceptive measures during the study period and within 6 months after the end of the study (effective contraceptive measures refer to sterilization, hormone devices in children, condoms, contraceptives / pills, abstinence or partner removal of vas deferens, etc.); men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 7) Understand and sign informed consent voluntarily with good compliance.

Exclusion criteria

Exclusion criteria: 1) The function of liver and kidney was seriously abnormal; 2) Preparation for pragnant, pregnant and lactating women; 3) Inability to lie flat for half an hour; 4) Suffering from claustrophobia or other mental disorders; 5) Other researchers considered it unsuitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
SUV/SUL;

Countries

China

Contacts

Public ContactYang Zhi

Nuclear Medicine Department, Beijing Cancer Hospital

pekyz@163.com+86 13701382886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026