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NCT04606329

To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)

Completed Phase 3 Last updated 10 February 2021
What this trial tests

Phase 3 trial testing LuminoMark inj.(Conc. for fluorescence) in Breast Diseases in 109 participants. Completed in 28 January 2021.

Timeline
20 July 2020
Primary endpoint
28 January 2021
28 January 2021

Quick facts

Lead sponsorHanlim Pharm. Co., Ltd.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment109
Start date20 July 2020
Primary completion28 January 2021
Estimated completion28 January 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Hanlim Pharm. Co., Ltd. — full company profile →

Who can join

Adults 19 to 80, any sex, with Breast Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Diseases

Currently open trials in the same condition.

Other Hanlim Pharm. Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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