Integrin SPECT/CT for the assessment of bevacizumab in rectal cancer.
Research type
Research Study
Full title
99mTc-maraciclatide SPECT/CT to measure response to combination chemotherapy and bevacizumab in high-risk rectal cancer: correlation with MRI RECIST, DW/ISW/DCE-MRI and 18FDG-PET.
IRAS ID
154220
Contact name
Gary Cook
Contact email
Sponsor organisation
King’s College London
Research summary
A single centre observational imaging study. A sub study to BACCHUS, an ongoing multi-centre trial.
The aim is to compare a relatively novel imaging study, 99mTc-maraciclatide SPECT/CT, with imaging studies already established in clinical practice, MRI and 18FDG-PET,
in primary rectal tumours; this will be done before and after chemotherapy including a drug named 'bevacizumab'.99mTc-maraciclatide is an investigational gamma-camera imaging agent, manufactured and supplied by GE Healthcare, which has already been successfully used in previous trials. It is able to identify the abnormal blood vessels associated with cancers.
Bevacizumab is a drug that slows the formation of new blood vessels in cancer, an essential process for the growth of solid tumours.
The aim of the BACCHUS trial is to evaluate the efficacy, toxicity and feasibility of two chemotherapy regimens (FOLFOX/bevacizumab and FOLFOXIRI/bevacizumab) in patients with rectal cancer. The aim of this substudy is to see how well 99mTc-maracilatide can show the changes in blood vessels associated with rectal tumours that occur as a result of treatment.
99mTc-maraciclatide scans (SPECT/CT) will be performed before and 6 weeks after a first course of chemotherapy in a subset of 25 patients who will also undergo, as per original BACCHUS trial protocol, 18FDG-PET and MRI examinations.
The study will be cost efficient, taking advantage of the BACCHUS trial infrastructure.
REC name
London - Westminster Research Ethics Committee
REC reference
14/LO/1261
Date of REC Opinion
29 Aug 2014
REC opinion
Favourable Opinion