Condition category
Cancer
Date applied
21/01/2016
Date assigned
22/01/2016
Last edited
21/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mr Pankaj Kumar Mishra

ORCID ID

http://orcid.org/0000-0002-0866-7825

Contact details

Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 850850
mishrapk_25@yahoo.com

Type

Scientific

Additional contact

Mr Joel Dunning

ORCID ID

Contact details

Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 850850
joedunning@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Lung Nodule Study Protocol : Version 1.1, 26th Feb 2015

Study information

Scientific title

A cohort study to investigate whether radiolabelled lung nodule localisation and excision is a technically successful and reliable method for excision, in patients with small lung nodule: a observational, prospective, pilot study

Acronym

Radio-labelled excision of lung nodules (RLELN)

Study hypothesis

Injection of small pulmonary nodules with radiolabelled material will improve accurate localisation, aid early resection of these nodules and will optimize patient management with resultant improved outcome.

Ethics approval

NRES Committee North West - Lancaster, 27/05/2015, ref: 15/NW/0369

Study design

Observational, prospective, pilot study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format. Please use the contact details below to request a patient information sheet.

Condition

Lung cancer or lung nodules of indeterminate origin

Intervention

Patients with very small nodules not amenable to excision via VATS surgery will be offered the option of radionucleotide injection of their nodules with VATS resection performed on the same day as an alternative to thoracotomy.

Patients will be identified from lung cancer multi-disciplinary (MDT) meetings. These MDT meetings are already an integral part of the researchers thoracic surgery services. They meet these patients to discuss their options for the management of these lung nodules and convey them the decision of the MDT. Patient makes a choice and an informed consent is taken. This new treatment option will be discussed as part of their treatment options.

The procedure will entail an admission to hospital (as per routine practice for patients who are due to undergo surgery). All patients will sign an informed consent form. They will have an injection of radio labelled substance under local anaesthesia by a consultant radiologist in the CT scan room. This is the same technique which is employed for CT guided lung biopsies which is a well-established procedure and the radiology team are well experienced in its conduct.

After this procedure the patient will return to the ward and later that day they will come to theatres, have a general anaesthetic and undergo a minimally invasive excision (key hole surgery) of the nodule in question.

The researchers will use the same key hole surgical technique that they routinely employ for larger nodules excision which they are able to see and feel, but the difference will be that they will use intraoperative gamma probe to detect the exact location of the nodule within the lung tissues. The recovery period from this operation will be about 2-4 days.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Technical success of lung nodule excision., assessed via histological confirmation of complete excision of nodule

Secondary outcome measures

1. Postoperative complications
2. Length of hospital stay
3. Conversion to Thoracotomy


Overall trial start date

10/12/2014

Overall trial end date

02/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients more than 16 years of age
2. Nodules less than 15 mm in size
3. Perceived difficulty in localising and excision of the nodule during surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Patients less than 16 years of age
2. Ability to remove mass without radiolabelling
3. Anatomic location of nodule makes it technically difficult to CT guided radiolabelling
4. Patient not willing to undergo the procedure
5. Inability to consent to the operation
6. Pregnancy

Recruitment start date

02/11/2015

Recruitment end date

02/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

James Cook University Hospital UK
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

James Cook University Hospital

Sponsor details

Research & Development Department
South Tees Hospitals NHS Foundation Trust
Academic Centre
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
01642 854089
Joe.Millar@stees.nhs.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

James Cook University Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The data from this study will be analysed and presented at national and International Meetings. The findings from the study will be published in peer reviewed journals.

Intention to publish date

01/11/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/10/2016: Cancer Help UK lay summary link added.