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

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

NCT ID: NCT06126705

Condition: Tumor, Solid

Conditions: Official terms:
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Radiation: 18F-AlF-FAPi-04
Description: Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.
Arm group label: Group A
Arm group label: Group B

Intervention type: Drug
Intervention name: Radiation: 18F-FDG
Description: Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.
Arm group label: Group A
Arm group label: Group B

Summary: To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer.

Detailed description: This is a prospective, single-center, two arms, open label, non-randomized study to evaluate the ability of 18F-AlF-FAPi-04 to detect FAP expressing cells in patients with solid tumor, evaluate its biological distribution characteristics, impact on clinical treatment plans, and evaluate imaging differences between different probes. Taking histopathology and imaging follow-up as gold standard, the sensitivity, specificity, and accuracy of 18F-AlF-FAPi-04 PET/CT will be calculated.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Affiliated Hospital of North Sichuan Medical College

Address:
City: Nanchong
Country: China

Status: Recruiting

Contact:
Last name: Huang xiaohong, MM

Phone: +86 158 8266 2030
Email: huangxiaohong2@126.com

Start date: July 18, 2023

Completion date: July 2024

Lead sponsor:
Agency: Affiliated Hospital of North Sichuan Medical College
Agency class: Other

Source: Affiliated Hospital of North Sichuan Medical College

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06126705