NCT04125511 is a EARLY_PHASE1 clinical trial of 68Ga-FAPI in IgG4-related Disease, sponsored by Peking Union Medical College Hospital.

Who is sponsoring NCT04125511?

NCT04125511 is sponsored by Peking Union Medical College Hospital.

What drugs are being tested in NCT04125511?

Interventions in NCT04125511: 68Ga-FAPI.

What condition does NCT04125511 study?

NCT04125511 studies IgG4-related Disease.

Is NCT04125511 still recruiting?

NCT04125511 is currently status unknown. Last updated 26 January 2021.

Last reviewed 2021-01-26 · How we verify

NCT04125511

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Characterizing IgG4-RD With 68Ga-FAPI PET/CT

Status unknown EARLY_PHASE1 Last updated 26 January 2021

What this trial tests

EARLY_PHASE1 trial testing 68Ga-FAPI in IgG4-related Disease in 100 participants. Status unknown.

Timeline

1 November 2019

Primary endpoint
1 October 2021

1 December 2021

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 November 2019
Primary completion	1 October 2021
Estimated completion	1 December 2021
Sites	1 location across China

Drugs / interventions tested

68Ga-FAPI — full drug profile →

Conditions studied

IgG4-related Disease — all drugs for IgG4-related Disease →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 90, any sex, with IgG4-related Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as IgG4-related disease.And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research.Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of IgG4-related disease.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Imaging Inflammation with Positron Emission Tomography.
Iking J, Staniszewska M, Kessler L, Klose JM, et al · · 2021 · cited 37× · PMID 33669804 · DOI 10.3390/biomedicines9020212
[<sup>68</sup>Ga]Ga-FAPI-04 PET/CT for subtyping and prognostication of IgG4-related disease.
Liu S, Pan Q, Zhang H, Peng L, et al · · 2026 · PMID 42129009 · DOI 10.1186/s13550-026-01451-7

Verify or expand the search:

Other trials of 68Ga-FAPI

Trials testing the same drug.

NCT07062523 — Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT · Phase 1, PHASE2 · recruiting
NCT05856409 — Clinical Application of 68Ga-FAPI PET Imaging in Detection of Ovarian Cancer Recurrence · unknown
NCT05803629 — Characterizing Histiocytosis With 68Ga-FAPI PET/CT · NA · unknown
NCT05686876 — FAPI-PET/CT in Psoriatic Arthritis · EARLY_PHASE1 · unknown
NCT05543954 — 68Ga-FAPI-RGD PET/CT Imaging in the Lung Cancer Patients · EARLY_PHASE1 · recruiting

Other recruiting trials for IgG4-related Disease

Currently open trials in the same condition.

NCT07025330 — A Study of Efgartigimod in Patients With IgG4-Related Disease · Phase 2 · recruiting
NCT06663618 — Short-term Glucocorticoid Combined with MMF for IgG4-RD · NA · recruiting

Other Peking Union Medical College Hospital trials

Trials by the same sponsor.

NCT07466251 — PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke · Phase 4 · not yet recruiting
NCT06743321 — Speech-to-speech Voice-cloning Care (SVCC) to Improve ICU-acquired Anxiety for Critically Ill Patients · NA · not yet recruiting
NCT07590336 — 68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma · Phase 1, PHASE2 · not yet recruiting
NCT07515976 — Mapping of Genomic Structural Variations in Major Birth Defects · not yet recruiting
NCT07386756 — Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04125511 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
Last refreshed: 26 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04125511.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing