Active — Not RecruitingNot Applicable

Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation

Australia60 participantsStarted 2024-03-21

Plain-language summary

This is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of using the FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System for mapping sentinel lymph nodes (SLNs) in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Iron compounds
✕. Polyacrylamide
✕. Polyethylene glycol (PEG) or has had an anaphylactic reaction to the Pfizer or Moderna COVID vaccines
✕. Iodine compounds
✕. Known or suspected hypersensitivity to FerroTrace®, or to any ingredients of FerroTrace®.

What they're measuring

SLN detection rate

Timeframe: Up to 14 days post surgery

Ultra-staging diagnostic value

Timeframe: Up to 14 days post surgery

Surgical quality

Timeframe: Up to 14 days post surgery

Trial details

NCT IDNCT05899985

SponsorFerronova Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-30

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