RecruitingNot ApplicableNCT07171190

Targeted Abdominal CT in Conjunction With Lung Cancer Screening

Targeted Abdominal CT in Conjunction With Lung Cancer Screening - a Pilot Study (TACTICAL1): a Randomised Controlled Pilot Study of Adding Abdominal Non-contrast CT to Lung Cancer Screening CT Thorax Amongst High Lung Cancer Risk Ever-smokers Aged 55-70.


Sponsor

University of Cambridge

Enrollment

6,272 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Early detection through screening can improve cancer survival by identifying it when it's most treatable. The NHS now offers Lung Cancer Screening (LCS) assessments to people aged 55-74 who have ever smoked. Those at higher risk of lung cancer are offered a lung scan. This group also has a high risk of developing abdominal cancers, such as kidney cancer. A recent study explored whether it would be feasible to extend the lung scan to include the abdomen. Results showed most participants supported this addition, and the number of serious findings was similar to those detected in UK breast or bowel cancer screening programmes. However, the abdominal scan was only offered on the day of the lung scan, giving little time for people to consider their decision. The process also added too much time to be practical for widespread implementation. This new study will: * Test whether mentioning the possible abdominal scan in the initial LCS invitation affects participation in LCS assessments. * Test new processes to assess if the abdominal scan can be added to the lung scan with minimal extra time. * Check if participants can be split between the lung scan only group and lung and abdominal scan group using an approach called 'cluster randomisation'. This will be important in case a bigger trial is needed. * See whether the additional processes are acceptable People aged 55-70 who are invited to the lung cancer screening will be eligible to take part in this study. Only those who are found to be at a high risk of lung cancer after their assessment, and therefore offered a lung scan, will be offered the abdominal scan, provided they have not had an abdominal scan in the previous 12 months or one booked in the next 3 months. This study will take place in two existing lung cancer screening locations in Yorkshire.


Eligibility

Min Age: 55 YearsMax Age: 70 Years

Inclusion Criteria10

  • For the individual level randomisation to invitation control or invitation intervention
  • Be eligible to be invited to the first round of a West Yorkshire and Harrogate LCS or a Humber and North Yorkshire Cancer Alliance LCS (i.e. have been identified as a smoker or ex-smoker and registered as living within the relevant LCS catchment area).
  • Be registered with a GP in England.
  • Be aged 55-70 years 364 days old at the date of invitation.
  • Have been individually randomised to the invitation intervention arm
  • Have booked in for a LCS assessment
  • Have been randomised to the scan intervention cluster
  • Be invited to attend for a LDCT Thorax based upon scores on either PLCOM2012 or Liverpool Lung Project (LLP) risk prediction models (PLCOM2012 risk of ≥1.51% over six years or LLPver2 five-year risk of ≥2.5%)14 during the LCS assessment.
  • Have attended the lung scan appointment
  • Have given electronic or written informed consent to participate

Exclusion Criteria11

  • • None
  • Eligibility criteria for the cluster level randomisation to scan intervention or scan control
  • Participant does not have capacity to give consent (standard criteria for assessing capacity apply).
  • Weight or physical size exceeds restrictions for scanner (\>200kg).
  • Participant unable to lie flat.
  • Poor physical fitness such that treatment with curative intent would be contra-indicated.
  • • Had an abdominal CT in the previous 12 months or has one booked within the next 3 months.
  • For HNY, this is checked before the LCS assessment. Therefore, participants will be excluded before the LCS assessment.
  • For WYH, this is only checked after the LCS assessment. Therefore, anyone having had an abdominal CT in the previous 12 months or with one booked within the next 3 months will be excluded at this point (see 8.6).
  • Eligibility criteria for the process evaluation Health care professionals: Healthcare professionals involved in the delivery of LCS in any of the study areas who agree to take part.
  • Participants: People individually randomised to the invitation intervention arm who attend the LCS assessment or the scanning unit within the study period and who agree to be interviewed.

Interventions

OTHERLung Cancer Screening Invitation Intervention

Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message

DIAGNOSTIC_TESTAbdominal scan intervention

Receiving an abdominal CT scan at the same time as the lung scan.


Locations(1)

Hull Teaching Hospitals Trust

Hull, United Kingdom

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NCT07171190


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