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

Tumor, Solid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06126705
• Other study ID #: TRX0109001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 18, 2023
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: Huang xiaohong, MM
• Phone: +86 158 8266 2030
• Email: huangxiaohong2[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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