Prostate MOlecular Targeting to Enhance surgery using IR800 IAB2M
Research type
Research Study
Full title
Investigation of novel molecular imaging techniques for precision surgery and genomic characterisation of high-risk prostate cancer using IR800 IAB2M
IRAS ID
234170
Contact name
Freddie C Hamdy
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-001332-19
Duration of Study in the UK
8 years, 5 months, 31 days
Research summary
This study aims to test new imaging techniques in high-risk prostate cancer patients, likely to have spreading disease that we cannot see with the naked eye. We will inject patients with a special ‘dye’ which carries a specific ‘marker’ (IR800 IAB2M) that will visualise prostate cells only, and use a special camera to make them shine in the dark. During key-hole surgery, the special dye and camera should allow the surgeon to see cancer cells, and the ‘shining’ areas will be sampled to check that they are cancerous. We will test whether the combination of the new dye and camera helps to see whether cancer has spread, and improves the precision of surgical removal of cancer at the same time as avoiding removing healthy tissue unnecessarily. This will happen in two stages:
1. Finding the best dose, timing of injection, and equipment settings in 20 men with high-risk prostate cancer. We will test: combinations of two doses of the dye (20mg-50mg), two time-intervals between the injection and surgery (24-48 hours), whether prostate cancer cells can be seen during surgery, and general safety of the technique. Both the marker and the special dye have been used separately and safely in patients previously.
2. Testing the technique in a further 50 patients, compared with a ‘control’ group of 50 similar patients who will not receive the imaging. The patients will be assigned randomly to either group following consent using a computer programme.
We will compare the groups to find out whether more cancer cells are removed using the new imaging, and more normal tissue is preserved to improve both cancer outcomes and urinary as well as sexual function. We will also find out whether the imaging technique has helped patients to improve their cure, and reduce treatment failure 5 years after surgery.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0103
Date of REC Opinion
27 Feb 2018
REC opinion
Favourable Opinion