Clinical trial Recruiting at 1 site Observational Ages 18 and up

Using AI to classify rectal cancer during surgery

Official title: CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery

Run by Mater Misericordiae University Hospital · NCT05793554 · Data updated 2026-11-12

This study is testing whether artificial intelligence can help doctors better identify rectal cancer during surgery for patients with larger polyps.

More Rectal Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorMater Misericordiae University Hospital
Academic / other
Locations1 site (Dublin, Ireland)
StatusRecruiting
StartedMarch 31, 2023
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedJanuary 17, 2025
Trial IDNCT05793554 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with confirmed or suspected rectal polyps or tumors larger than 2cm undergoing surgical intervention.

Probably not a fit

Patients who are pregnant, have significant renal or hepatic impairment, or other significant health issues may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate the use of artificial intelligence in classifying rectal cancer and polyps during real-time surgical procedures. It focuses on patients with rectal polyps larger than 2cm, which pose significant diagnostic challenges due to the risk of containing cancer. The study will assess the effectiveness of AI in improving the accuracy of pre-surgical classifications, potentially leading to better treatment decisions and outcomes. Participants will include those undergoing surgical intervention for suspected or confirmed rectal tumors.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and improved treatment strategies for patients with rectal cancer.

How similar studies have gone: Other studies have shown promise in using AI for cancer classification, but this specific application in real-time surgery is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Participants with a confirmed or suspected rectal polyp/tumour measuring greater than 2cm undergoing surgical intervention or assessment OR Patients with a known rectal cancer undergoing surgical intervention or assessment, including those post neo adjuvant therapy.
* Participant is willing and able to give informed consent for participation in the study. ● Male or Female, aged 18 years or above.
* Clinically fit for elective intervention

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy within three months of the study
* Significant renal or hepatic impairment.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. ● Allergy to intravenous contrast agent or iodides
* Other contraindications to ICG including concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.

Where it's running

  • Mater Misericordiae University Hospital
    Dublin, Ireland, Ireland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.