NCT03546478 is a EARLY_PHASE1 clinical trial of 99mTc-ABH2 in Breast Cancer, sponsored by Peking Union Medical College Hospital.

Who is sponsoring NCT03546478?

NCT03546478 is sponsored by Peking Union Medical College Hospital.

What drugs are being tested in NCT03546478?

Interventions in NCT03546478: 99mTc-ABH2.

What condition does NCT03546478 study?

NCT03546478 studies Breast Cancer.

Is NCT03546478 still recruiting?

NCT03546478 is currently completed. Last updated 6 June 2018.

Last reviewed 2018-06-06 · How we verify

NCT03546478

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

99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

Completed EARLY_PHASE1 Last updated 6 June 2018

What this trial tests

EARLY_PHASE1 trial testing 99mTc-ABH2 in Breast Cancer in 32 participants. Completed in 18 May 2018.

Timeline

24 June 2015

Primary endpoint
24 May 2017

18 May 2018

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	32
Start date	24 June 2015
Primary completion	24 May 2017
Estimated completion	18 May 2018
Sites	1 location across China

Drugs / interventions tested

99mTc-ABH2 — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 29 to 76, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Publications & conference data

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

HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
Interactions Between Tumor Biology and Targeted Nanoplatforms for Imaging Applications.
Azizi M, Dianat-Moghadam H, Salehi R, Farshbaf M, et al · · 2020 · cited 30× · PMID 34093104 · DOI 10.1002/adfm.201910402
Review: Radionuclide Molecular Imaging Targeting HER2 in Breast Cancer with a Focus on Molecular Probes into Clinical Trials and Small Peptides.
Ge S, Li J, Yu Y, Chen Z, et al · · 2021 · cited 17× · PMID 34770887 · DOI 10.3390/molecules26216482
Molecular probes targeting HER2 PET/CT and their application in advanced breast cancer.
Gao F, Liu F, Wang J, Bi J, et al · · 2024 · cited 10× · PMID 38466436 · DOI 10.1007/s00432-023-05519-y

Verify or expand the search:

Other trials of 99mTc-ABH2

Trials testing the same drug.

NCT06194565 — 99mTc-ABH2 SPECT/CT in Breast Cancer · NA · unknown

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · 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 NCT03546478 (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: 6 June 2018

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/NCT03546478.

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