Granulomatosis With Polyangiitis (Wegener's)NCT07712172
Assessing Granulomatosis With Polyangiitis Activity: 18F-FDG PET/CT vs BVAS v3
An observational study of Granulomatosis With Polyangiitis (Wegener's), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis (Wegener's)
- What is being tested?
- 18F-FDG and 18F-FDG PET/CT
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2025to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed/ relapsed active GPA patients with BVAS v3 more than or equal to 1.
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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh, Chandigarh, 160012
About this study
Official title: 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?
Read the 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.
- Being tested
- 18F-FDG, 18F-FDG PET/CT
- Keywords
- GPA, Wegener's Granulomatosis, BVAS, Granulomatosis with polyangiitis, PET CT, 18F-FDG
- Medical subject headings
- Granulomatosis with Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDGDrug
18 F-FDG PET/CT was done for patients with active GPA
18F-FDG PET/CTDevice
Use of 18F-FDG PET/CT scan in patients with active GPA
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH ACTIVE GPA | Not described Receives: Drug: 18F-FDG; Device: 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis With Polyangiitis (Wegener's)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Dr Harmandeep Singh, MD, Principal investigator, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712172
- Sponsor's protocol ID
- ChandigarhPGIMER
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07712172
- Acronym / sponsor ID
- ChandigarhPGIMER
- Keywords
- GPA, Wegener's Granulomatosis, BVAS, Granulomatosis with polyangiitis, PET CT, 18F-FDG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH ACTIVE GPA | – | Drug: 18F-FDG, Device: 18F-FDG PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed/ relapsed active GPA patients with BVAS v3 more than or equal to 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG18 F-FDG PET/CT was done for patients with active GPA | Drug | PATIENTS WITH ACTIVE GPA |
| 18F-FDG PET/CTUse of 18F-FDG PET/CT scan in patients with active GPA | Device | PATIENTS WITH ACTIVE GPA |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Harmandeep Singh, MD principal investigator
Postgraduate Institute of Medical Education and Research, Chandigarh, 160012
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatosis With Polyangiitis (Wegener's), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.