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Recruiting Phase 1 NCT05121779

NCT05121779 Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04 and 18F-FDG PET-CT

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Clinical Trial Summary
NCT ID NCT05121779
Status Recruiting
Phase Phase 1
Sponsor Peking Union Medical College Hospital
Condition Pulmonary Fibrosis
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2021-11-18
Primary Completion 2025-12-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
68Ga-FAPI18F-FDG

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 80 participants in total. It began in 2021-11-18 with a primary completion date of 2025-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * suspected or confirmed pulmonary fibrosis patients; * signed written consent. Exclusion Criteria: * pregnancy; * breastfeeding; * known allergy against FAPI * any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Contact & Investigator

Central Contact

Zhaohui Zhu, MD

✉ 13611093752@163.com

📞 86-13611093752

Principal Investigator

Zhaohui Zhu, MD

PRINCIPAL INVESTIGATOR

Peking Union Medical College Hospital

Frequently Asked Questions

Who can join the NCT05121779 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT05121779 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT05121779 currently recruiting?

Yes, NCT05121779 is actively recruiting participants. Contact the research team at 13611093752@163.com for enrollment information.

Where is the NCT05121779 trial being conducted?

This trial is being conducted at Beijing, China.

Who is sponsoring the NCT05121779 clinical trial?

NCT05121779 is sponsored by Peking Union Medical College Hospital. The principal investigator is Zhaohui Zhu, MD at Peking Union Medical College Hospital. The trial plans to enroll 80 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: November 2026  ·  Data Methodology