iSmaRT: Imaging small renal tumours
| ISRCTN | ISRCTN15730405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15730405 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | iSmaRT - protocol v0.1 19/09/2018 |
| Sponsor | Guy's and St Thomas' and King's College London |
| Funder | Royal College of Radiologists |
- 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| adedayo.oke@gstt.nhs.uk |
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 |
|---|---|
| vicky.goh@kcl.ac.uk |
Scientific
Becket House
5th Floor
1 Lambeth Palace Rd
London
SE1 7EU
United Kingdom
| Phone | +44 207 188 7188 |
|---|---|
| Muskaan.kaur@gstt.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective single centre observational cohort study |
| Secondary study design | Cohort study |
| Study type | 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(s) |
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 |
| Key secondary outcome measure(s) |
1. Correlations between DECT and CTp parameters |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
