Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT

NCT05121779 | Recruiting Phase 1

• 1 other identifier: PUMCH-NM-FAPI-PF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

68Ga-fibroblast activating protein inhibitors(FAPI) has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of Pulmonary fibrosis than 18F-FDG PET/CT.

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic value

  Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 18F-FDG PET/CT

  through study completion, an average of 1 year

Secondary Outcomes (2)

• FAPI expression and SUV

  through study completion, an average of 1 year

• therapy response

  through study completion, an average of 1 year

Study Arms (1)

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

EXPERIMENTAL

All patients diagnosed with Lung fibrosis underwent 68Ga-FAPI PET/CT and 18F-FDG PET/CT.

Drug: 68Ga-FAPI; Drug: 18F-FDG

Interventions

68Ga-FAPI DRUG

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of pulmonary fibrosis by PET/CT.

Also known as: 68Ga-fibroblast activating protein inhibitors

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

18F-FDG DRUG

Intravenous injection of one dosage of 4.44-5.55 MBq(0.12-0.15mCi)/Kg 18F-FDG. Tracer doses of 18F-FDG will be used to image lesions of pulmonary fibrosis by PET/CT.

Also known as: 18F-Fluorodeoxyglucose

68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• suspected or confirmed pulmonary fibrosis patients;
• signed written consent.

You may not qualify if:

• pregnancy;
• breastfeeding;
• known allergy against FAPI
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

68Ga-FAPI; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Zhaohui Zhu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-13611093752; 13611093752@163.com

Jiarou Wang, MS

CONTACT

86-13628477019; pumc_wangjiarou@student.pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 18, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)