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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp. The smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised We have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps. The goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
Contact Information
Primary
Alice Moynihan
alice.moynihan@ucd.ie
353 (0)1 716 4000
Time Frame
Start Date: 2023-03-31
Estimated Completion Date: 2027-03
Participants
Target number of participants: 600
Treatments
Rectal tumour without prior evidence of cancer
400 patients with a known rectal tumour that has not demonstrated evidence of cancer to date - may be benign or indeterminate on biopsy or without biopsy performed to date.~Patients in this cohort will undergo examination under anaesthesia as is standard of care. During this examination the pattern of fluorescence seen in NIR camera within the tumour will be observed following administration of ICG (dose 0.25mg/kg) and recorded. Following this, patients will continue with standard of care at the discretion of their surgeon.~The operative video will be uploaded to a secure cloud based system and annotated by the surgeon where further mathematical analysis will be carried out for the purposes of tissue classification.
Rectal tumour previously confirmed as cancerous
200 patients with a rectal tumour that has proven previously to contain cancer. Both patients who have and have not undergone neoadjuvant therapy are suitable for inclusion in this group.~Patients in this group will undergo the same processes as the patients in cohort 1.
Related Therapeutic Areas
Sponsors
Collaborators: Universita Degli Studi di Torino, Krankenhaus der Barmherzigen Bruder Graz, Pintail LTD, Ziekenhuis Oost-Limburg Autonome Verzorginginstelling, Institut de recherche Contre Les Cancers de L'appareil Digestif, Horizon Europe, Københavns Universitet, Stitchting VUMC, Arctur Racunalniski Inzeniring Doo, Penn State University, Stitchting EAES
Leads: Mater Misericordiae University Hospital

This content was sourced from clinicaltrials.gov