Using 18F-AlF-FAPi-04 PET/CT to detect solid tumors

18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor

This study is testing a new type of imaging called 18F-AlF-FAPi-04 PET/CT to see if it can help find solid tumors in patients more effectively.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of North Sichuan Medical College (Academic / other)
• Locations: 1 site (Nanchong, Sichuan)
• Trial ID: NCT06126705 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of 18F-AlF-FAPi-04 PET/CT imaging in identifying primary and metastatic lesions in patients with solid tumors. It is a prospective, single-center, open-label study that includes two arms and focuses on the detection of FAP-expressing cells. The study will assess the biological distribution of the imaging agent, its impact on clinical treatment plans, and compare imaging results with other probes. Sensitivity, specificity, and accuracy will be calculated using histopathology and imaging follow-up as the gold standard.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases.

Not a fit: Patients who have previously received FAP-targeted radioligand therapy or are participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of diagnosing solid tumors and guide treatment decisions.

How similar studies have performed: While similar imaging approaches have been explored, the specific use of 18F-AlF-FAPi-04 PET/CT in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Obtain/sign informed consent.
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:

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, 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.

Where this trial is running

Nanchong, Sichuan

• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Huang xiaohong, MM — Affiliated Hospital of North Sichuan Medical College
• Study coordinator: Huang xiaohong, MM

Conditions Tumor, Solid