NCT06143540

Brief Summary

The goal of this observational study is to examine clinical utility of 18F-FAPI-RGD PET/CT imaging in evaluating connective tissue disease-associated interstitial lung disease. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

August 16, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

November 16, 2023

Last Update Submit

November 21, 2023

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

  • Correlation between clinical indicators and PET/CT results

    Correlation of clinical pulmonary function indexes, HRCT, laboratory examination indexes and 18F-FAPI-RGD PET/CT results

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinically suspected or diagnosed connective tissue disease-associated interstitial lung disease

You may qualify if:

  • Age 18 and above
  • Patients who have been diagnosed with, or are clinically highly suspected of ILD
  • Patients who have been diagnosed with, or are clinically highly suspected of CTD-ILD

You may not qualify if:

  • Pregnant or breastfeeding
  • Patients with tumor, other respiratory diseases, and lung surgery
  • Abnormal cardiopulmonary function or mental state, unable tolerate PET/CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate senior physician

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 22, 2023

Study Start

August 16, 2023

Primary Completion

May 1, 2024

Study Completion

July 1, 2024

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

CN(1)