Diagnosis and staging

1.2 Effectiveness of diagnostic and staging investigations

Terminology used for cancer staging classification changes over time. The guideline recommendations were developed using the 7th edition of the American Joint Committee on Cancer (AJCC) staging system.

1.2.1

Only use sputum cytology for investigation in people with suspected lung cancer who have centrally placed nodules or masses and who decline or cannot tolerate bronchoscopy or other invasive tests. [2005]

1.2.2

Offer people with known or suspected lung cancer a contrast-enhanced chest CT scan to further the diagnosis and stage the disease. Include the liver, adrenals and lower neck in the scan. Use contrast medium with caution in people with known renal impairment. [2005, amended 2019]

1.2.3

When assessing mediastinal and chest wall invasion:

be aware that CT alone may not be reliable
consider other techniques such as ultrasound if there is doubt
be aware that surgical assessment may be necessary if there are no contraindications to resection. [2005]

1.2.4

Ensure that all people with lung cancer who could potentially have treatment with curative intent are offered positron emission tomography CT (PET‑CT) before treatment. [2011]

1.2.5

Every cancer alliance should have a system of rapid access to PET‑CT scanning for people who are eligible for this. [2005, amended 2019]

1.2.6

Do not routinely use MRI to assess the stage of the primary tumour (T‑stage) in non-small-cell lung cancer (NSCLC). [2005]

1.2.7

Use MRI when necessary to assess the extent of disease, for people with superior sulcus tumours. [2005]

1.2.8

Offer endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for biopsy of paratracheal and peri-bronchial intra-parenchymal lung lesions. [2011]

1.2.9

Every cancer alliance should have at least 1 centre with EBUS or endoscopic ultrasound (EUS), or both, to ensure timely access. [2011]

1.2.10

Audit the local test performance of EBUS-TBNA and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). [2011, amended 2019]

1.2.11

When taking samples, ensure they are adequate (without unacceptable risk to the person) to permit pathological diagnosis, including tumour subtyping and assessment of molecular markers. [2011, amended 2019]

1.2.12

See the National Genomics Test Directory for guidance on next-generation sequencing (NGS) panels to guide treatment. [2019, amended 2026]

Why the committee made the recommendations

Effectiveness of diagnostic and staging investigations

Clinical audit is an important tool for maintaining high standards in the use of endobronchial ultrasound‑guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound‑guided fine‑needle aspiration (EUS-FNA). This is consistent with the British Thoracic Society guideline and quality standards.

EBUS-TBNA and EUS-FNA

The recommendations cover:

initial invasive investigations for people with an intermediate probability of mediastinal malignancy
subsequent investigations for people with a high probability of mediastinal malignancy, when neck ultrasound and biopsy are negative.

In these circumstances, when compared with alternative investigations, EBUS-TBNA and EUS-FNA:

produce a diagnosis and stage faster than bronchoscopy or CT-guided biopsy
are more acceptable to patients than surgery
reduce the need for further investigations and hospital visits compared with bronchoscopy.

Surgical mediastinal staging

There is evidence that surgical staging is useful when EBUS-TBNA and/or EUS-FNA are negative but clinical suspicion of mediastinal malignancy is high. While there are potential harms from the invasive nature of surgical staging, there is no evidence that these outweigh the benefits in this population.

Procedures that were not recommended

Transthoracic needle biopsy, bronchoscopy and non-ultrasound-guided TBNA are no longer recommended for staging lung cancer in intrathoracic lymph nodes because:

bronchoscopy and non-ultrasound-guided TBNA are unlikely to reach the minimum sensitivity required by the British Thoracic quality standards and
they may discourage people from having more effective procedures (such as EBUS-TBNA) and subsequent investigations.

The word 'fibreoptic' has been removed because bronchoscopy can be fibreoptic, video or hybrid.

How the recommendations might affect practice

The recommendations on PET-CT reflect current practice, so will not incur an extra cost.

The recommendations on EBUS-TBNA and EUS-FNA will reinforce best practice and result in a more streamlined diagnostic service with more timely diagnosis and staging.

The surgical mediastinal staging recommendation will also reinforce best practice and restrict this procedure to people most likely to benefit.

Full details of the evidence and the committee's discussion are in evidence review A: investigations for staging the mediastinum.

Sequence of investigations

1.2.13

Choose investigations that give the most information about diagnosis and staging with the least risk to the person. Think carefully before performing a test that gives only diagnostic pathology when information on staging is also needed to guide treatment. [2011]

1.2.14

Perform contrast-enhanced CT of the chest, liver adrenals and lower neck before any biopsy procedure. [2005, amended 2019]

Peripheral primary tumour

1.2.15

When choosing diagnostic and staging investigations, take into account that some people with lung cancer will not be well enough for treatment with curative intent. [2011, amended 2019]

1.2.16

Offer image-guided biopsy to people with peripheral lung lesions when treatment can be planned based on this test. [2011, amended 2019]

1.2.17

Biopsy any enlarged intrathoracic nodes (10 mm or larger maximum short axis on CT) or other lesions in preference to the primary lesion if determination of nodal stage affects treatment. [2011, amended 2019]

Central primary tumour

1.2.18

Offer flexible bronchoscopy to people with central lesions on CT if nodal staging does not influence treatment. [2011, amended 2019]

Intrathoracic lymph node assessment

1.2.19

For people with lung cancer who could potentially have treatment with curative intent and have a low probability of nodal malignancy (lymph nodes below 10 mm maximum short axis on CT), offer PET-CT as the preferred first test after CT. [2011, amended 2019]

1.2.20

For people with suspected lung cancer who have enlarged intrathoracic lymph nodes (lymph nodes greater than or equal to 10 mm short axis on CT) and who could potentially have treatment with curative intent, offer PET-CT (if not already done), followed by EBUS‑TBNA or EUS‑FNA, or both. [2019]

1.2.21

If nodal status would affect the treatment plan, evaluate PET-CT-positive or enlarged intrathoracic nodes using a systematic approach (sampling any suspicious node on CT, PET or USS) with:

either EBUS‑TBNA or EUS‑FNA or
both EBUS‑TBNA and EUS‑FNA. [2019]

1.2.22

Consider surgical mediastinal staging for people with a negative EBUS‑TBNA or EUS‑FNA if clinical suspicion of nodal malignancy is high and nodal status would affect their treatment plan. [2019]

We have produced an algorithm on intrathoracic nodal staging of NSCLC in patients being considered for radical treatment.

Why the committee made the recommendations

EBUS-TBNA and EUS-FNA

initial invasive investigations for people with an intermediate probability of mediastinal malignancy
subsequent investigations for people with a high probability of mediastinal malignancy, when neck ultrasound and biopsy are negative.

In these circumstances, when compared with alternative investigations, EBUS-TBNA and EUS-FNA:

produce a diagnosis and stage faster than bronchoscopy or CT-guided biopsy
are more acceptable to patients than surgery
reduce the need for further investigations and hospital visits compared with bronchoscopy.

Full details of the evidence and the committee's discussion are in evidence review A: investigations for staging the mediastinum.

Further staging

1.2.23

Confirm the presence of isolated distant metastases or synchronous tumours by biopsy or further imaging (for example, MRI or PET-CT) in people for whom treatment with curative intent is an option. [2011]

1.2.24

Do not offer dedicated brain imaging to people with clinical stage 1 NSCLC who have no neurological symptoms and are having treatment with curative intent. [2019]

1.2.25

Offer contrast-enhanced brain CT to people with clinical stage 2 NSCLC who are having treatment with curative intent. If CT shows suspected brain metastases, offer contrast-enhanced brain MRI. [2019]

1.2.26

Offer contrast-enhanced brain MRI for people with stage 3 NSCLC who are having treatment with curative intent. [2019]

1.2.27

Offer people with clinical features suggestive of intracranial pathology CT of the head followed by MRI if normal, or MRI as an initial test. [2011]

1.2.28

Perform an X-ray as the first test for people with localised signs or symptoms of bone metastasis. If the results are negative or inconclusive, offer bone scintigraphy or an MRI scan. [2005]

1.2.29

Avoid bone scintigraphy when PET-CT has not shown bone metastases. [2011]

Why the committee made the recommendations

Brain imaging is helpful before starting treatment with curative intent, because if brain metastases are detected then the treatment plan is likely to change. However, routine brain imaging is expensive, and the evidence showed that it does not always offer a good balance of benefits and costs.

In people with stage 2 and 3a disease, the benefits of brain imaging outweigh the costs because:

brain metastases are more common than in stage 1 disease
people can start early treatment for metastases if they are identified, which improves prognosis
some people with brain metastases will not have radical treatment (depending on factors such as the number of metastases, prognosis and patient preference), and this reduces costs.

In people with clinical stage 1 non-small-cell lung cancer (NSCLC) and no neurological symptoms, the prevalence of detectable brain metastases is fairly low (around 4%) compared with people with stage 2 or 3a disease. People with stage 1 NSCLC who do have brain metastases often still have radical lung treatment, which is much more rarely the case for people with stage 3a NSCLC. Overall, the lower prevalence of metastases and smaller reduction in numbers of people having radical treatment mean that the benefits of brain imaging in this population are too low to justify the costs.

The 2018 review only examined the clinical and cost effectiveness of imaging after the treatment plan has been decided, but the committee noted that it could be more efficient to conduct CT brain imaging alongside initial staging CT. With this in mind, the committee made a recommendation for research on routine brain imaging with CT at initial diagnosis and/or staging.

How the recommendations might affect practice

Practice in this area is variable. The committee estimated that the recommendations will increase the number of people who have brain imaging. In turn, they thought this should prevent the use of treatment options (such as lobectomy and sublobar resection) in some patients for whom it is not expected to be beneficial. The recommendations may also lead to an increase in radical radiotherapy, stereotactic radiosurgery and brain surgery. These treatments would be expected to improve the person's prognosis, although each treatment would carry its own risks and side effects.

Full details of the evidence and the committee's discussion are in evidence review B: brain imaging for people with NSCLC selected for treatment with curative intent.

Service delivery

1.2.30

Provide treatment without undue delay for people who have lung cancer that is suitable for radical treatment or chemotherapy, or who need radiotherapy or ablative treatment for relief of symptoms. [2005, amended 2019]

Multidisciplinary teams

1.2.31

Refer all people with a suspected diagnosis of lung cancer to a member of a lung cancer multidisciplinary team (usually a chest physician). [2005]

1.2.32

Discuss the care of all people with a working diagnosis of lung cancer at a lung cancer multidisciplinary team meeting. [2005]

Fast track lung clinics

1.2.33

Provide fast track lung cancer clinics for investigating suspected lung cancer. [2005]

Cancer clinical nurse specialists

1.2.34

All cancer units or centres should have 1 or more trained lung cancer clinical nurse specialists to:

see people before, at the time of and after diagnosis
provide continuing support
facilitate communication between the secondary care team (including the multidisciplinary team), the person's GP, the community team and the person with lung cancer
help people access advice and support whenever they need it. [2005, amended 2019]