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

Launched by AFFILIATED HOSPITAL OF NORTH SICHUAN MEDICAL COLLEGE · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method called 18F-AlF-FAPi-04 PET/CT to see if it can help doctors better diagnose solid tumors, which are abnormal growths found in various parts of the body. The goal is to find out if this imaging can identify both primary tumors and those that have spread to other areas in patients who have certain types of cancer, such as digestive tumors or head and neck cancers.

To participate in the trial, patients need to be at least 18 years old and have a confirmed diagnosis of a solid tumor. They should be able to provide informed consent and have good overall health. Participants will undergo imaging tests and may need to have follow-up visits for 3 to 6 months. It’s important to know that some patients may not be eligible, such as those who have had specific prior treatments or serious medical conditions. Overall, this trial aims to explore a potentially helpful tool for better understanding and managing solid tumors.

Gender

ALL

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.