iSmaRT: Imaging small renal tumours

ISRCTN	ISRCTN15730405
DOI	https://doi.org/10.1186/ISRCTN15730405
Secondary identifying numbers	iSmaRT - protocol v0.1 19/09/2018

Submission date: 30/08/2019
Registration date: 30/10/2019
Last edited: 03/05/2023

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-improving-the-assessment-of-kidney-treatment-ismart

Contact information

Dr Adedayo Oke
Public

Department of Clinical Imaging and Medical Physics
Floor 4, Lambeth Wing
St. Thomas' Hospital
London
SE1 7EH
United Kingdom

Phone	+44 (0)207 188 8381
Email	adedayo.oke@gstt.nhs.uk

Prof Vicky Goh
Scientific

King's College London
Imaging Research Office
Level 1 Lambeth Wing
St Thomas' Hospital
Westminster Bridge Rd
London
SE1 7EH
United Kingdom

Phone	+44 (0)2071885550
Email	vicky.goh@kcl.ac.uk

Miss Muskaan Kaur
Scientific

Becket House
5th Floor
1 Lambeth Palace Rd
London
SE1 7EU
United Kingdom

Phone	+44 207 188 7188
Email	Muskaan.kaur@gstt.nhs.uk

Study information

Study design	Prospective single centre observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Dual source CT assessment of ablation success in renal tumours
Study acronym	iSmaRT
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	19/09/2018
Completion date	31/12/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	48
Key inclusion criteria	Patients with T1 renal tumours referred for ablation
Key exclusion criteria	1. Standard contraindications for contrast-enhanced CT including poor renal function (as per hospital protocol) 2. Previous contrast agent allergy
Date of first enrolment	01/06/2019
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's and St Thomas' NHS Foundation Trust

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St Thomas' and King's College London
University/education

16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Phone	+44 (0)20 7188 7188 ext 56030
Email	reza.razavi@kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Research organisation

Royal College of Radiologists
Private sector organisation / Associations and societies (private and public)

Alternative name(s): The Royal College of Radiologists, RCR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

03/05/2023: A scientific contact was changed.
25/04/2023: The recruitment end date was changed from 31/01/2024 to 31/12/2025.
12/01/2022: The following changes were made to the trial record:
1. The recruitment end date has been changed from 31/01/2022 to 31/01/2024.
2. The overall trial end date was changed from 31/12/2022 to 31/12/2025.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2025.
4. Contact details updated.
11/01/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2021 to 31/01/2022.
2. The overall trial end date was changed from 31/12/2021 to 31/12/2022.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
26/06/2020: Cancer Research UK lay summary link added to plain English summary field.
02/09/2019: Trial’s existence confirmed by London - City and East Research Ethics Committee.