Human Trial, page-246

Combidex phase 1 and 2 trial results were showed good image results (2mm detection compared to 7mm standard detecion)
, out off 310 patients 4 had adverse effects off grade 1 ( flushing and dry mouth). They applied for approval of use in America twice and Europe twice but were rejectead due to procedures in the process of the SPIONs were not followed and issues with the trial process. Combidex is now called Ferrotran and started phase 3 trial in july 2020, in that time it has been used in Switzerland under a compassionate use program. The issue for approval will be if trials 1 and 2 can be used to jump to trial 3.