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Prospective multi-institutional study to evaluate the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy(FUSION-03)

Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy - Evaluation of the positive axillary lymph nodes of the breast cancer patients using the virtual sonography during neoadjuvant chemotherapy

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054462
Enrollment
62
Registered
2024-05-22
Start date
2024-04-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients with posotive lymph node metastasis who need neoadjuvant chemotherapy

Interventions

None listed

Sponsors

Gifu University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Primary breast cancer with pathologically node-positive 2)cT0-T4, cN1-3, M0(cStage IIA-IIIC) 3)patient who need NAC 4)more than 20yo, male and female 5)PS 0-2 6)available for insertion of the intra-tumoral marker 7)agree to participate in this trial

Exclusion criteria

Exclusion criteria: 1)imposible to insert intra-tumoal marker 2)not agreed to perform TAS&Ax 3)impossible to perform NAC becauseof medical problem, HBV/HVC-positive case in acceptable with anappropriate treatment 4)pregnant 5)mental disorder 6) decision not appropriate to join the trial by PI

Design outcomes

Primary

MeasureTime frame
Detection rate of the marker in intra-tumoal tumror by virtual sonography aftr neoadjuvant chemotherapy

Secondary

MeasureTime frame
1) Number of lymph nodes in TAS & Ax specimen 2) False positive rate of positive lymph nods in TAS & Ax specimen 3) Radiological detection rate of tje intra-tumoal tumor by US-US fusion, US-CT fusion image 4) Time till detection of the intra-tumoal tumor by virtual somnography 5) Adverse events 6)Radiological change of the marker located in the positive lymph node

Countries

Japan

Contacts

Public ContactManabu Futamura

Department of breast surgery Gifu University Graduate school of Medicine Department of breast surgery Gifu University Graduate school of Medicine

futamura.manabu.m3@f.gifu-u.ac.jp0582306000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026