Using AI to classify rectal cancer during surgery
CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery
This study is testing whether artificial intelligence can help doctors better identify rectal cancer during surgery for patients with larger polyps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mater Misericordiae University Hospital Academic / other |
| Locations | 1 site (Dublin, Ireland) |
| Trial ID | NCT05793554 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed or suspected rectal polyps or tumors larger than 2cm undergoing surgical intervention.
Not a fit: Patients who are pregnant, have significant renal or hepatic impairment, or other significant health issues may not benefit from this study.
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 performed: Other studies have shown promise in using AI for cancer classification, but this specific application in real-time surgery is relatively novel.
Eligibility criteria
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 this trial is running
Dublin, Ireland
- Mater Misericordiae University Hospital — Dublin, Ireland, Ireland (Recruiting)
Study contacts
- Principal investigator: Ronan Cahill — University College Dublin
- Study coordinator: Alice Moynihan
- Email: alice.moynihan@ucd.ie
- Phone: 353 (0)1 716 4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.