Plain English Summary
Dr Adedayo Oke
Department of Clinical Imaging and Medical Physics
St. Thomas' Hospital
0207 188 8381
Prof Vicky Goh
King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
iSmaRT - protocol v0.1 19/09/2018
Dual source CT assessment of ablation success in renal tumours
1. To assess if dual energy computed tomography (DECT) assessment of tumour vascularisation improves the diagnostic accuracy for residual disease and prediction of early recurrence following ablation of renal tumours.
2. To assess if evaluation of perfusion improves the sensitivity and specificity for residual disease compared to standard morphological assessment following small renal tumour ablation.
3. To assess if qualitative perfusion assessment with DECT (iodine mapping, iodine concentration) is comparable to quantitative perfusion CT (CTp) (BF,BV,PS) in distinguishing between ablation zone and residual disease.
Approved 22/01/2019, London - City and East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3, Block B, Lewins Mead, Bristol, BS1 2NT, UK; 0207 104 8026; email@example.com), ref: 18/LO/2005
Prospective single centre observational cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Dual source computed tomography including dual-energy CT (DECT) and perfusion-CT (CTp) quantification of vascularisation pre- and day 1 post-ablation improves the assessment of residual disease versus complete ablation and predict for early recurrence in renal cancer.
Both DSCT (140kVSn/80kV, weight dependent contrast (Omnipaque 350) administration) and CTp (80-100kV, 40mL Omnipaque 350 IV) will be performed pre and d1 post ablation on a 3rd-generation Dual Source CT (Force, Siemens). A subgroup of 10 patients will undergo an additional CTp study on d14 post-ablation.
Follow up imaging will be performed at 3 and 9 months with DSCT using the same acquisition protocol as baseline DSCT.
Primary outcome measure
1. Sensitivity and specificity for residual and recurrent disease measured by i) morphological CT; ii) DECT iodine distribution; iii) CTp BF, BV and PS at baseline, 3-months, 9-months
2. Quantitative cut-offs that maximise sensitivity for residual and recurrent disease
Secondary outcome measures
1. Correlations between DECT and CTp parameters
2. Reproducibility of DECT and CTp parameters
3. Differences CTp measurements between d1 and d14
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients with T1 renal tumours referred for ablation
Target number of participants
Participant exclusion criteria
1. Standard contraindications for contrast-enhanced CT including poor renal function (as per hospital protocol)
2. Previous contrast agent allergy
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
St Thomas' Hospital Westminster Bridge Road,
Guy's and St Thomas' and King's College London
16th Floor Tower Wing
Great Maze Pond
020 7188 7188 ext 56030
Royal College of Radiologists
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Results and Publications
Publication and dissemination plan
At the end of the study, the results will be presented at meetings and published in a medical journal. All information will be anonymous and at no time will it be possible for patients to be identified individually.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Prof Vicky Goh (firstname.lastname@example.org). Access would be to imaging protocol and anonymised results, on a case by case basis.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)