Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tze Wah

ORCID ID

Contact details

Radiology/Ultrasound Department
Lincoln Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom
+44 0113 206 4330
Tze.wah@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436165595

Study information

Scientific title

Acronym

Study hypothesis

The principal aims are to assess the completeness of the RF ablation and the accuracy of radiology imaging (with contrast enhanced ultrasound, CT and MRI) in assessing the tumour for residual RCC after treatment by correlation with pathological examination of the explanted specimen.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cancer: Renal

Intervention

1. 5 patients in the control group (surgery only)
2. 5 patients will undergo percutaneous RFA of their RCC 14 days before laparoscopic or open partial nephrectomy

Please note, the trial was stopped due to a lack of recruitment.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The efficacy of RFA using the current technique in achieving complete tumour ablation will be assessed. Greater than 90% tumour destruction is desirable with the current technique.
For contrast enhanced US, CT and MRI the positive predictive value in assessing tumour destruction will be evaluated by correlation with the histological analysis of the explanted kidneys. Accuracy of greater than 80% for each test would be desirable and all modalities should be comparable in predicting tumour destruction

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2005

Overall trial end date

01/06/2007

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

10 candidates for partial nephrectomy ie with solitary RCC (less than 4 cm).

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2005

Recruitment end date

01/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Radiology/Ultrasound Department
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Research organisation

Funder name

Leeds Teaching Hospitals NHS Trust - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CIRSE (Cardiovascular and Interventional Radiological Society of Europe)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes