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Radionuclide-labeled tumor-associated fibroblast activation protein (FAP) inhibitor in PET imaging of solid tumors

Radionuclide-labeled tumor-associated fibroblast activation protein (FAP) inhibitor in PET imaging of solid tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044131
Enrollment
Unknown
Registered
2021-03-11
Start date
2021-03-08
Completion date
Unknown
Last updated
2021-07-21

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

Conditions

Solid Tumors

Interventions

Index test:DOTA-FAPI-04

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-75 years old, male and female, with ECoG score of 0 or 1; 2. Subjects with head and neck tumor, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, solid tumor of bone or soft tissue sarcoma or suspected tumor who are to undergo pathological biopsy or tumor surgical treatment in the near future (within 2 months); 3. Patients with expected survival >= 12 weeks; 4. Patients whose blood routine and liver and kidney function meet the following criteria: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/L, PLT >= 100 x 10^9 / L, Hb >= 90g / L; PT or APTT <= 1.5 ULN; liver and kidney function: T-Bil <= 1.5 ULT (upper limit of normal value), ALT / AST <= 2.5 ULN or <= 5 ULT (liver metastasis subjects), ALP <= 2.5 ULN (if there is bone metastasis or liver metastasis, ALP <= 4.5 ULN), bun <= 1.5 ULT, SCR <= 1.5 ULT; 5. Patients with at least one measurable target lesion according to recist 1.1; 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 device in the child's office, condom, contraceptive / agent, abstinence or partner's vasectomy, etc.); men should agree to take contraceptive measures during the study period and within 6 months after the end of the study period; 7. Patients who can understand and voluntarily sign informed consent and have good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with severe abnormal liver and kidney functions; 2. Pregnant, pregnant and lactating women; 3. Patients who can't lie flat for half an hour; 4. Patients who refused to join the clinical study; 5. Patients with claustrophobia or other mental diseases; 6. Other researchers think it is not suitable to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
SUVmax;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactYue Chen

The Affiliated Hospital of Southwest Medical University

chenyue5523@126.com+86 830-3165720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 2, 2026