Assessing Granulomatosis With Polyangiitis Activity: 18F-... | NCT07712172

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

NCT07712172

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Last Update Posted

Jul 17, 2026Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Granulomatosis With Polyangiitis (Wegener's)

Interventions

18F-FDG
18F-FDG PET/CT

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

May 30, 2026Actual

Completion Date

May 30, 2026Actual

First Submitted Date

Jun 22, 2026

First Submission Date that Met QC Criteria

Jul 16, 2026

First Posted Date

Jul 17, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2026

Last Update Posted Date

Jul 17, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rajender Kumar, Additional Professor, Post Graduate Institute of Medical Education and Research, ChandigarhPrincipal Investigator

Lead Sponsor

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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?

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PATIENTS WITH ACTIVE GPA			Drug: 18F-FDG Device: 18F-FDG PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FDG	Drug	18 F-FDG PET/CT was done for patients with active GPA	PATIENTS WITH ACTIVE GPA

Outcomes Module

Primary Outcomes

Measure	Description	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		Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Harmandeep Singh, MD	Postgraduate Institute of Medical Education and Research, Chandigarh, 160012	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh		Chandigarh	Chandigarh	160012	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014890	Granulomatosis with Polyangiitis

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D056648	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019788	Fluorodeoxyglucose F18

Ancestor Terms

ID	Term
D003847	Deoxyglucose
D003837	Deoxy Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided