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

NCT ID: NCT06126705

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-18
• Study Completion Date: 2024-07-31

Brief 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.

Conditions

Tumor, Solid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Radiation: 18F-AlF-FAPi-04

Intervention Type: DRUG

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.

Radiation: 18F-FDG

Intervention Type: DRUG

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.

Group B

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.

Group Type: EXPERIMENTAL

Radiation: 18F-AlF-FAPi-04

Intervention Type: DRUG

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.

Radiation: 18F-FDG

Intervention Type: DRUG

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.

Interventions

Radiation: 18F-AlF-FAPi-04

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.

Intervention Type: DRUG

Radiation: 18F-FDG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huang xiaohong, MM

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of North Sichuan Medical College

Locations

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huang xiaohong, MM

Role: CONTACT

huangxiaohong2@126.com

+86 158 8266 2030

Facility Contacts

Huang xiaohong, MM

Role: primary

huangxiaohong2@126.com

+86 158 8266 2030

Other Identifiers

TRX0109001

Identifier Type: -

Identifier Source: org_study_id