Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer

NCT05617742 | Unknown

• 1 other identifier: 202101258A0
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.

Conditions

Lung Cancer

Keywords

68Ga-FAPI-46; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• To define the diagnostic performance 68Ga-FAPI PET

  To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.

  Through study completion, 2 years

Secondary Outcomes (1)

• To determine the safety profile of 68Ga-FAPI PET

  Up to 7 days post injection with 68Ga-FAPI-46

Study Arms (1)

68Ga-FAPI-46 PET Scan

EXPERIMENTAL

A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination.

Diagnostic Test: 68Ga-FAPI-46

Interventions

68Ga-FAPI-46 DIAGNOSTIC_TEST

68Ga-FAPI-46 is a radioactive diagnostic agent for PET imaging in the detection of Fibroblast Activation Protein (FAP) positive tumor cells in cancer patients

68Ga-FAPI-46 PET Scan

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 20 years
• Informed consent obtained from patients and families
• Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery
• Patients scheduled to undergo FDG-PET examination
• Performance status: 0, 1, 2, 3

You may not qualify if:

• Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients
• Patients with mainly malignant pleural effusion without other measurable lesions
• Undergoing irradiation at accrual
• Active infection or other serious underlying medical conditions not compatible with study entry
• History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Nuclear Medicine, Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kung-Chu Ho, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kung-Chu Ho, MD

CONTACT

+886975365783; b8301068@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

TW (1)