Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Dr Adedayo Oke
ORCID ID
Contact details
Department of Clinical Imaging and Medical Physics
Floor 4
Lambeth Wing
St. Thomas' Hospital
London
SE1 7EH
United Kingdom
0207 188 8381
adedayo.oke@gstt.nhs.uk
Type
Scientific
Additional contact
Prof Vicky Goh
ORCID ID
Contact details
King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
+442071885550
vicky.goh@kcl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
iSmaRT - protocol v0.1 19/09/2018
Study information
Scientific title
Dual source CT assessment of ablation success in renal tumours
Acronym
iSmaRT
Study hypothesis
Aims:
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.
Ethics approval
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; nrescommittee.london-cityandeast@nhs.net), ref: 18/LO/2005
Study design
Prospective single centre observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Renal cancer
Intervention
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.
Intervention type
Other
Phase
Drug names
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
19/09/2018
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with T1 renal tumours referred for ablation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
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
01/06/2019
Recruitment end date
31/01/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
St Thomas' Hospital
Westminster Bridge Road,
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' and King's College London
Sponsor details
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
020 7188 7188 ext 56030
reza.razavi@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Royal College of Radiologists
Alternative name(s)
RCR
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
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 (vicky.goh@kcl.ac.uk). Access would be to imaging protocol and anonymised results, on a case by case basis.
Intention to publish date
31/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list