Assessing Granulomatosis With Polyangiitis Activity: 18F-FDG PET/CT vs BVAS v3

July 16, 2026 updated by: Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh

Assessment of Disease Activity in Patients With Granulomatosis With Polyangiitis Using 18F-Fluorodeoxyglucose Positron Emission Tomography/ Computed Tomography and Its Correlation With Birmingham Vasculitis Activity Score Version 3

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients age more than 18 with active GPA were recruited and 18F-FDG PET/CT was done after clinical assessment and evaluation. BVAS v3 score was calculated and then patients underwent 18F-FDG PET/CT. Findings of the scans were evaluated by expert nuclear medicine physicians and various semiquantitative parameters were calculated. Sensitivity was then calculated and correlation of BVAS v3 score was done with the calculated semiquantitative parameters.

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chandigarh
      • Chandigarh, Chandigarh, India, 160012
        • Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: Patients with newly diagnosed or relapsed active GPA, Age more than or equal to18 years.

Exclusion Criteria: Pregnant/ lactating women and non-consenting adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PATIENTS WITH ACTIVE GPA
Drug: 18F-FDG
18 F-FDG PET/CT was done for patients with active GPA
Device: 18F-FDG PET/CT
Use of 18F-FDG PET/CT scan in patients with active GPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Investigators

  • Principal Investigator: Dr Harmandeep Singh, MD, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

May 30, 2026

Study Completion (Actual)

May 30, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChandigarhPGIMER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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