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

NCT06126705 | Unknown Early Phase 1

• 1 other identifier: TRX0109001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor, Solid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Biodistribution of 18F-AlF-FAPi-04

  120 minutes after tracer injection

Study Arms (2)

Group A

EXPERIMENTAL

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; Drug: Radiation: 18F-FDG

Group B

EXPERIMENTAL

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; Drug: Radiation: 18F-FDG

Interventions

Radiation: 18F-AlF-FAPi-04 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 A; Group B

Radiation: 18F-FDG 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 A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of North Sichuan Medical College: lead

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Huang xiaohong, MM

  Affiliated Hospital of North Sichuan Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang xiaohong, MM

CONTACT

+86 158 8266 2030; huangxiaohong2@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: July 18, 2023
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)