NCT05859763

Brief Summary

This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 16, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

May 5, 2023

Last Update Submit

May 5, 2023

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    Qualitative and semi-quantitative analysis (T/N ratio of lesions and adjacent normal tissue, and early and late imaging) of 99mTc-HFAPI SPECT/CT for pulmonary fibrosis

    through study completion, an average of 1.5 years

Study Arms (1)

Patients diagnosed with pulmonary fibrosis

EXPERIMENTAL

Patients of Pulmonary Fibrosis SPECT/CT imaging: The patients were subcutaneously injected with 99mTc-HFAPI and underwent SPECT/CT imaging.

Drug: 99mTc-HFAPI

Interventions

99mTc-HFAPIDRUG

Each patient receive a intravenous injection of 99mTc-HFAPI, and undergo SPECT/CT scan within specified time.

Patients diagnosed with pulmonary fibrosis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 conditions that are considered by the investigator to be likely to seriously interfere with study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Dongcheng, 100010, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yu Liu, MD

CONTACT

18511071577liuyu@pumch.cn

Hongli Jing, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 16, 2023

Study Start

December 12, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

CN(1)