NCT07712172

Brief Summary

The goal of this observational study is to quantify activity and extent of disease in patients with GPA using 18F-FDG PET/CT. The main questions it aims to answer are: Sensitivity of 18 F-FDG PET/CT in patients with GPA? Correlation of 18F-FDG PET/CT semi-quantitative parameters with BVAS v3?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

June 22, 2026

Last Update Submit

July 16, 2026

Conditions

Granulomatosis With Polyangiitis (Wegener's)

Keywords

GPAWegener's GranulomatosisBVASGranulomatosis with polyangiitisPET CT18F-FDG

Outcome Measures

Primary Outcomes (1)

  • Per-patient sensitivity of 18F-FDG PET/CT for detection of clinically active GPA and correlation of 18 F-FDG PET/CT semiquantitative parameters with BVAS v3

    Baseline

Study Arms (1)

PATIENTS WITH ACTIVE GPA

Drug: 18F-FDGDevice: 18F-FDG PET/CT

Interventions

18F-FDGDRUG

18 F-FDG PET/CT was done for patients with active GPA

PATIENTS WITH ACTIVE GPA
18F-FDG PET/CTDEVICE

Use of 18F-FDG PET/CT scan in patients with active GPA

PATIENTS WITH ACTIVE GPA

Eligibility Criteria

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

Newly diagnosed/ relapsed active GPA patients with BVAS v3 more than or equal to 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Granulomatosis with Polyangiitis

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Dr Harmandeep Singh, MD

    Postgraduate Institute of Medical Education and Research, Chandigarh, 160012

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 17, 2026

Study Start

January 1, 2025

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

July 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)