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PET/CT imaging of fluorine-18 labeled FAP probes in patients with solid tumors

PET/CT imaging of fluorine-18 labeled FAP probes in patients with solid tumors

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077391
Enrollment
Unknown
Registered
2023-11-07
Start date
2023-07-15
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

Solid tumors

Interventions

Cohort 2: Imaging follow-up or pathological puncture results
Index test:18F-AlF-FAPi-04 PET/CT
18F-FDG PET/CT

Sponsors

Affiliated Hospital of North Sichuan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Prior to participating in the study, a signed informed consent form must be obtained. 2.Age =18 years, male or female patients. 3.Histologically or cytologically confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases, 4.Cohort 1: Patients with operable or borderline operable resection, scheduled for primary lesion resection and peripheral lymph node dissection, and suspected presence of peripheral lymph node or distant metastasis; The pathological results of the primary lesion and lymph node dissection were obtained. Cohort 2: Patients with confirmed or suspected postoperative recurrence or advanced metastasis by routine imaging had at least one measurable lesion; Patients who can undergo imaging follow-up for 3 to 6 months or can undergo pathological biopsy. 5.The ECOG score is 0-2 6.Patients with adequate organ function.

Exclusion criteria

Exclusion criteria: 1.Previously received FAP-targeted radioligand therapy. 2.Patients are participating in any other clinical trials or receiving investigational drugs. 3.Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system. 4.Patients with other malignancies that may interfere with disease assessment, who have a prior history of malignancy but have been adequately treated, who have not been treated for more than 3 years prior to enrollment, and who have no evidence of recurrence are eligible to participate in the study. 5.Comorbidities with serious or poorly controlled medical conditions, including but not limited to hard-to-control infections (including severe or poorly recovered COVID-19 infections), known active hepatitis B or C, or other conditions that investigators believe may impair study participation or collaboration. 6.A physical or psychiatric history that may interfere with the purpose and evaluation of the study, or any condition in which the investigator determines that the patient is incapable of cooperating with imaging and procedures. 7.Patients who do not consent to effective contraception or restricted sexual practices. 8.There are other conditions that the investigator deems unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Positive prediction rate;Negative prediction rate;

Countries

China

Contacts

Public ContactXiaohong Huang

Affiliated Hospital of North Sichuan Medical College

824425104@qq.com+86 158 8266 2030

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026