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.

• Register: ISRCTN
• Last refreshed on: 17 May 2021
• Main ID: ISRCTN95525805
• Date of registration: 22/01/2016
• Prospective Registration: No
• Primary sponsor: James Cook University Hospital
• Public 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.
• 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
• Date of first enrolment: 02/11/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN95525805
• Study type: Observational
• Study design: Observational, prospective, pilot study (Diagnostic)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Joel Dunning

• Name: Pankaj Kumar Mishra

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Lung cancer or lung nodules of indeterminate origin
Cancer
Lung cancer

Intervention(s)

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

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

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

Source(s) of Monetary Support

James Cook University Hospital (UK)

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 02/02/2017