NCT04554719 is a NA clinical trial of 68Ga-DOTA-FAPI in Malignant Neoplasm, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

What drugs are being tested in NCT04554719?

Interventions in NCT04554719: 68Ga-DOTA-FAPI, PET/MR, PET/CT.

What condition does NCT04554719 study?

NCT04554719 studies Malignant Neoplasm.

Is NCT04554719 still recruiting?

NCT04554719 is currently status unknown. Last updated 14 February 2023.

Last reviewed 2023-02-14 · How we verify

NCT04554719

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

Clinical Application of Fibroblast Activation Protein PET/MRI for Diagnosis and Staging in Malignant Tumors

Status unknown NA Last updated 14 February 2023

What this trial tests

NA trial testing 68Ga-DOTA-FAPI in Malignant Neoplasm in 500 participants. Status unknown.

Timeline

22 May 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	500
Start date	22 May 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across China

Drugs / interventions tested

68Ga-DOTA-FAPI — full drug profile →
PET/MR
PET/CT

Conditions studied

Malignant Neoplasm — all drugs for Malignant Neoplasm →

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 18 to 80, any sex, with Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. Malignant tumor is composed of tumor cells and tumor stroma, which occupies the vast majority of the tumor. Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth, invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in normal tissues and organs is very low. So it becomes an excellent target for cancer diagnosis and treatment. Radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically target to FAP as a tracer for PET imaging can be applied for targeted diagnosis and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a new novel positron tracer has shown to be with good application potential. In this prospective study, the investigators will use integrated PET/MR, and PET/CT with the agent 68Ga-FAPI and conventional imaging agent \[F-18\] fluorodeoxyglucose (18F-FDG) to diagnose and stage various cancers, the aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some cancers.

Publications & conference data

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

A head-to-head comparison of 68Ga-DOTA-FAPI-04 and 18F-FDG PET/MR in patients with nasopharyngeal carcinoma: a prospective study.
Qin C, Liu F, Huang J, Ruan W, et al · · 2021 · cited 75× · PMID 33609152 · DOI 10.1007/s00259-021-05255-w
Non-malignant findings of focal 68Ga-FAPI-04 uptake in pancreas.
Zhang X, Song W, Qin C, Liu F, et al · · 2021 · cited 43× · PMID 33452634 · DOI 10.1007/s00259-021-05194-6
Increased uptake of 68Ga-DOTA-FAPI-04 in bones and joints: metastases and beyond.
Qin C, Song Y, Liu X, Gai Y, et al · · 2022 · cited 39× · PMID 34241652 · DOI 10.1007/s00259-021-05472-3
Bête Noire of Chemotherapy and Targeted Therapy: CAF-Mediated Resistance.
De P, Aske J, Sulaiman R, Dey N. · · 2022 · cited 20× · PMID 35326670 · DOI 10.3390/cancers14061519
Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management.
Qin C, Song Y, Gai Y, Ruan W, et al · · 2022 · cited 19× · PMID 35657428 · DOI 10.1007/s00259-022-05847-0
Radiotracers to Address Unmet Clinical Needs in Cardiovascular Imaging, Part 2: Inflammation, Fibrosis, Thrombosis, Calcification, and Amyloidosis Imaging.
Stendahl JC, Kwan JM, Pucar D, Sadeghi MM. · · 2022 · cited 16× · PMID 35772956 · DOI 10.2967/jnumed.121.263507
Fibroblast activation protein-based theranostics in pancreatic cancer.
Cheng CS, Yang PW, Sun Y, Song SL, et al · · 2022 · cited 13× · PMID 36263225 · DOI 10.3389/fonc.2022.969731
Cancer-Associated Fibroblasts: Heterogeneity, Cancer Pathogenesis, and Therapeutic Targets.
Li Y, Liu Q, Jing X, Wang Y, et al · · 2025 · cited 11× · PMID 40656546 · DOI 10.1002/mco2.70292

Verify or expand the search:

Other trials of 68Ga-DOTA-FAPI

Trials testing the same drug.

NCT05030597 — Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma · recruiting

Other recruiting trials for Malignant Neoplasm

Currently open trials in the same condition.

NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07487883 — Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors · recruiting
NCT07252739 — KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) · Phase 2 · recruiting
NCT07247110 — A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) · Phase 1 · recruiting
NCT07131007 — Construction and Evaluation of Tumor Immunotherapy and Organ Damage Early Warning System Based on Multi-omics · recruiting

Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials

Trials by the same sponsor.

NCT07521124 — ABC Maintenance Therapy for AML · NA · not yet recruiting
NCT07497243 — X-ray Assisted Diagnostic System · not yet recruiting
NCT07520123 — Union-FAST: An Intelligent-Agent Intervention to Increase Antiviral Treatment Uptake in Diagnosed-but-Untreated Hepatiti · NA · not yet recruiting
NCT06970262 — FMT for Lung and Associated-organ Rescue Efficacy in ARDS Patients · NA · recruiting
NCT07509424 — Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Lo · Phase 2 · 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 NCT04554719 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Last refreshed: 14 February 2023

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