CEeDD: Sonosensitive particles and ultrasound to enhance drug delivery
Research type
Research Study
Full title
CEeDD: A First-in-Human Clinical Investigation of Cavitation-Enhanced Drug Delivery to Solid Tumours by co-Administration of Sonosensitive Particles and Application of Extracorporeal Ultrasound in Patients with Colorectal Metastases to the Liver
IRAS ID
289760
Contact name
Rachel Kerr
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance Team
ISRCTN Number
17598292
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
This study will look at a new intervention in patients with bowel cancer that has spread to the liver (called colorectal cancer liver metastases (CRLM)). This is required because bowel cancer is very common, and despite best efforts, once CRLM are present, chances of cure are small. The planned intervention combines specialist ultrasound treatment delivered to the body through the skin over the liver area (SonoTran System), and the injection of microscopic cup-shaped ‘particles’ (SonoTran Particles) that are given into the vein. The hope is that when these two are delivered together (termed the SonoTran Platform) they will help ‘push’ standard cancer drugs deeper into the tumours and increase the effectiveness of those drugs (both standard chemotherapy drugs, and newer larger cancer antibody drugs). The study is split into three parts. In the first part (cohort 1) patients who have received all standard drugs for their bowel cancer, or who are having a break off standard drugs, will receive one ‘treatment’ with the specialist ultrasound (called SonoTran System-SS) and one injection of the SonoTran Particles(SP), in order to assess safety of the new intervention. In Cohort 2, patients who are about to have their CRLMs removed by surgery will, the day prior, receive one low dose each of the anticancer drugs irinotecan and cetuximab and, in addition, half of the patients will receive an injection of SonoTran Particles and a single ’treatment’ with SonoTran ultrasound. The tumours (CRLMs) that are removed will be examined to see how much and how deep the drugs get into them. In Cohort 3, patients who have not yet received treatment for their CRLMs will receive repeated cycles of standard chemotherapy drugs (5-fluoruracil, irinotecan and cetuximab) and half of them will also receive SonoTran particles and SonoTran Ultrasound. Tumour responses will be measured and compared.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0090
Date of REC Opinion
31 Jul 2021
REC opinion
Favourable Opinion