Condition category
Cancer
Date applied
30/08/2019
Date assigned
30/10/2019
Last edited
30/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

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

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial’s existence confirmed by London - City and East Research Ethics Committee.