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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tumor, Solid

Intervention / Treatment
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* Drug: Radiation: 18F-AlF-FAPi-04
* Drug: Radiation: 18F-FDG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtain/sign informed consent. Age ≥18 years, male or female patients. Histologically or cytologically confirmed digestive tumors, head and neck squamous cell carcinoma, or peritoneal metastases. 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. The ECOG score is 0-2 Patients with adequate organ function. Exclusion Criteria: Previously received FAP-targeted radioligand therapy. Patients are participating in any other clinical trials or receiving investigational drugs. Patients with central nervous system (CNS) metastases with symptoms or receiving glucocorticoid therapy to maintain functional integrity of the nervous system. 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. 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. 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. Patients who do not consent to effective contraception or restricted sexual practices. There are other conditions that the investigator deems unsuitable for participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients who are surgically resectable or borderline surgically resectable plan to undergo primary lesion resection and peripheral lymph node dissection, and suspect the presence of peripheral lymph nodes or distant metastasis; Pathological results of postoperative primary lesion and lymph node dissection can be obtained | Drug: Radiation: 18F-AlF-FAPi-04<br>* 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.<br>Drug: Radiation: 18F-FDG<br>* 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.<br>|
| Experimental: Group B<br>For patients diagnosed or suspected of postoperative recurrence or late metastasis through routine imaging examination, there is at least one measurable lesion (with a short diameter of ≥ 1.5cm for lymph node lesions and ≥ 1cm for non lymph node lesions); Patients who can undergo imaging follow-up for 3-6 months or undergo pathological biopsy and puncture. | Drug: Radiation: 18F-AlF-FAPi-04<br>* 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.<br>Drug: Radiation: 18F-FDG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group A: Sensitivity and Specificity of 18F-AlF-FAPi-04 | Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using surgical histopathological results as truth standard | 6 months after last dose administration | 
| Group B: Sensitivity and Specificity of 18F-AlF-FAPi-04 | Performance [sensitivity, specificity, accuracy] of 18F-AlF-FAPi-04 PET imaging to detect FAP-expressing cells, using imaging follow-up or histopathological puncture results as truth standard | 6 months after last dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of 18F-AlF-FAPi-04 | The biodistribution of 18F-AlF-FAPi-04 in normal and cancer tissues of patients with various malignancies will be measured by average and maximum standardized uptake value (SUVmean and SUVmax) | 120 minutes after tracer injection |