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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07885683). This is a study registration, not published results. Lead sponsor: Imagion Biosystems, Inc.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: HER2-positive Breast Cancer. Interventions: COMBINATION_PRODUCT: The MagSense® HER2 Imaging Agent (MSH2IA). Primary outcome measures: Phase 1b: Level of Fe in blood , 24 hours post injection; Phase 2 (Imaging Schedule): Dose and Imaging schedule for MSH2IA , 24 hours post injection; Phase 2 (Diagnostic Performance): Diagnostic performance comparison between MSH2IA and SOC , 24 hours post injection. Brief summary: This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate image timing, and diagnostic performance of a selected dose of MSH2IA when administered by subareolar or peritumoral injection. No hypothesis testing is planned. Comparative statistics will be used to generate hypotheses to be tested in subsequent studies.