What this Trial Is About

Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist. Thus, there is an unmet need for better clinical staging of rectal cancer in early stages. If new imaging techniques for clinical staging of early rectal cancer are developed an opportunity for increased treatment by local excision and decreased unnecessary radical surgery would be possible. NanoEcho Particle-1 (NEP-1, Ferumoxtran Lyophilisate 20 mg Fe/mL) will be used, in combination with NanoEcho Imaging Device, to enhance the signal in the detection and identification of possible spread of rectal cancer to nearby rectal regional lymph nodes by magnetomotive ultrasound (MMUS) technology. NEP-1 is an ultrasmall superparamagnetic iron oxide (USPIO)-based contrast agent. It belongs to the specific contrast agents-group, which are specific to reticuloendothelial system (liver, spleen, lymph nodes, bone marrow), mainly represented by iron oxide nanoparticles coated with macromolecules such as dextran in the presence of adjuvants (mineral salts, polyhydric alcohols, etc.). It belongs to the USPIO sub-group (with a mean particle diameter of 30 nm. The NanoEcho Imaging Device is based on the MMUS technology. It aims to identify possible spread of rectal cancer to nearby rectal regional lymph nodes by visualisation of the movement, generated by the nanoparticles (nTrace). The iron oxide-based nanoparticles, NEP-1, are administered submucosally at four separate administration sites locally in rectum, close to the suspected tumour area. After some time allowing the particles to spread, the MMUS probe, dressed in a probe cover with ultrasound gel inside, is inserted into the rectum. The nanoparticles are set in motion by a magnetic field, introduced by a rotating magnet located inside the probe. The motion of the tissue, the so-called tissue displacement, is detected with ultrasound and called NanoEcho visualisation of the movement generated by the nanoparticles (nTrace) and is visualised on the screen of the NanoEcho Imaging Device. The higher the concentration of the nanoparticles, the stronger the nTrace signal. Based on the distribution pattern of the particles, the system aims to support the user in distinguishing between healthy and metastatic lymph nodes located nearby the tumour within the rectal region. Part A In Part A (healthy volunteers) of the trial, NEP-1 will be administered on a single occasion, followed by four MMUS-assessments, in four ascending dose groups of three participants each. Part B In Part B (rectal cancer patients) of the trial, NEP-1 will be administered on a single occasion, followed by a MMUS assessment in a maximum of ten patients with rectal cancer. The dose level of NanoEcho Particle-1 (Ferumoxtran) to be used and the timepoint for the MMUS assessment will be decided based on Part A.

To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.