Abdominal CT offered alongside lung screening for people who have smoked

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.

We will test whether mentioning a possible extra abdominal CT in the lung screening invitation changes whether people aged 55–70 who have ever smoked attend their lung screening appointment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6272 (estimated)
• Ages: 55 Years to 70 Years
• Sex: All
• Sponsor: University of Cambridge (Academic / other)
• Locations: 1 site (Hull)
• Trial ID: NCT07171190 on ClinicalTrials.gov

What this trial studies

This trial randomises individuals to receive a standard lung screening invitation or an invitation that mentions a possible additional abdominal CT, and it randomises screening sites to offer the abdominal scan or not during the screening process. Participants are people eligible for the first round of local NHS lung cancer screening programs who are aged around 55–70 and registered with a GP in England. The study will measure whether invitation wording affects attendance, whether offering an abdominal CT is practical without adding unacceptable time or burden, and the number and seriousness of abdominal findings detected. Scans and follow-up are delivered within participating regional screening services, with lead coordination from the University of Cambridge and clinical sites such as Hull Teaching Hospitals.

Who should consider this trial

Good fit: Ideal candidates are people aged 55–70 (up to 70 years and 364 days at invitation) who have ever smoked, are registered with a GP in England, and live in the participating lung screening catchment areas.

Not a fit: People outside the eligible age range, not registered with an English GP, who have never smoked, or who choose not to undergo imaging are unlikely to receive direct benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help detect kidney and other abdominal conditions earlier in people at higher risk by combining an abdominal CT with routine lung screening.

How similar studies have performed: Earlier feasibility work showed most participants supported adding an abdominal scan and that serious findings occurred at rates similar to UK breast and bowel screening, though same-day consent and extra scanning time were problematic.

Eligibility criteria

1. For the individual level randomisation to invitation control or invitation intervention

   Inclusion criteria: To be randomised at the individual level to receive an invitation letter for LCS (standard of care; invitation control) versus invitation letter for LCS with potential for an additional abdominal scan (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.

   Exclusion criteria

   • None
2. Eligibility criteria for the cluster level randomisation to scan intervention or scan control

   Inclusion criteria a): To be eligible for the cluster level randomisation the participant must:
   * Have been individually randomised to the invitation intervention arm
   * Have booked in for a LCS assessment

   Inclusion criteria b): To receive the CT Thorax plus ANCCT, the participant must:
   * 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 criteria

   Existing LCS exclusion criteria:
   * 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.
   * Participants who have had a full CT Thorax that meets the image reconstruction parameters of the programme in the last 12 months are not excluded from the lung screening programme, but would have their CT Thorax appointment deferred until 12 months have elapsed since that last scan, provided they still meet all inclusion criteria and have no exclusion criteria - if the deferred appointment is within the timeframe for TACTICAL1, they remain eligible but if deferred appointment is outside the timeframe for TACTICAL1 they would not be eligible.

   Additional TACTICAL1 exclusion criteria:

   • 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).
3. 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.

Where this trial is running

Hull

• Hull Teaching Hospitals Trust — Hull, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Grant Stewart

Conditions Renal Cell Carcinoma; Kidney Cancers; AAA - Abdominal Aortic Aneurysm; Renal Stones; Screening; NHS Lung Cancer Screening; Kidney cancer; Abdominal cancer