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.

ISRCTN	ISRCTN95525805
DOI	https://doi.org/10.1186/ISRCTN95525805
Secondary identifying numbers	Lung Nodule Study Protocol : Version 1.1, 26th Feb 2015

Submission date: 21/01/2016
Registration date: 22/01/2016
Last edited: 07/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-radioactive-labelling-to-help-remove-lung-nodules

Contact information

Mr Pankaj Kumar Mishra
Public

Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

ORCID ID	0000-0002-0866-7825
Phone	01642 850850
Email	mishrapk_25@yahoo.com

Mr Joel Dunning
Scientific

Department of Cardiothoracic Surgery
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	01642 850850
Email	joedunning@nhs.net

Study information

Study design	Observational, prospective, pilot study
Primary study design	Observational
Secondary study design
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format. Please use the contact details below to request a patient information sheet.
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
Study acronym	Radio-labelled excision of lung nodules (RLELN)
Study objectives	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(s)	NRES Committee North West - Lancaster, 27/05/2015, ref: 15/NW/0369
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	10/12/2014
Completion date	02/02/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Total final enrolment	23
Key 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
Key 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
Date of first enrolment	02/11/2015
Date of final enrolment	02/02/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

James Cook University Hospital UK

Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

James Cook University Hospital
Research organisation

Research & Development Department
South Tees Hospitals NHS Foundation Trust
Academic Centre, The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	01642 854089
Email	Joe.Millar@stees.nhs.uk
"ROR"	https://ror.org/02vqh3346

Funders

Funder type

Hospital/treatment centre

James Cook University Hospital (UK)

No information available

Results and Publications

Intention to publish date	01/11/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.
IPD sharing plan

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results		07/05/2021	No	Yes
Results article	01/02/2018	07/05/2021	Yes	No
HRA research summary		28/06/2023	No	No

Editorial Notes

07/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
21/10/2016: Cancer Help UK lay summary link added.