Colon cancer
Conditions
Interventions
Product Name: EMI-137
Pharmaceutical Form: Powder for injection
Sponsors
The University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 years or over. • Patients with a diagnosis of colonic cancer (the disease can be of any radiological TMN stage and be located anywhere from the caecum to the up to but not including the rectosigmoid junction) confirmed on colonoscopy or CT/CT colonography. • Patients with or without distant visceral or lymphatic metastatic disease. • Patients with synchronous colon cancers or polyps can participate. • American Society of Anaesthesiologists (ASA) classification =3. • Normal hepatic and renal function (eGFR =60 mls/min/1.73m2 and bilirubin within institutional limits and/or ALT =2.5x upper limit of institutional normal value) on serum laboratory blood tests performed =30 days prior to EMI-137 administration. • Female participants who are surgically sterile (documented bilateral oophorectomy and/or hysterectomy), post-menopausal (cessation of menses for more than 1 year), or pre-menopausal with two negative urine pregnancy tests performed within 24 hours of administration of EMI-137. • Pre-menopausal female participants of child-bearing potential who agree to employ two method of contraception as defined in eligibility criteria during the study period and for 90 days after EMI-137 administration. • Male participants with a non-pregnant female partner. Male participants with a pre-menopausal female partner of child-bearing potential who agree to use two forms of contraception during the study period and for at least 90 days after receiving EMI-137. (The only permissible exception would be if the participant had undergone documented bilateral orchidectomy or their female partner is post-menopausal (cessation menses >1 year) partner or has undergone documented bilateral oophorectomy and/or hysterectomy). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Patients who are participating in another intra-operative fluorescence study, or have participated in another fluorescence study within 3 months of the planned surgical procedure. • Received an investigational medicinal product at any dose within 28 days of planned EMI-137 administration. • Patients with pre-existing inflammatory bowel disease. • Patients who have undergone neoadjuvant chemotherapy to treat the colon cancer. • Patients with impaired renal function (eGFR 2.5x upper limit of normal) on serum laboratory blood tests performed witihn 30 days of EMI-137 administration. • Pregnant and breastfeeding woman. • Pre-menopausal woman planning to become pregnant within 90 days of receiving EMI-137; or pre-menopausal women of child-bearing potential who refuse to use two forms of contraception for at least 90 days after receiving EMI-137 • Male patients with a currently pregnant partner or male patients who are planning to conceive a pregnancy with a female partner within 90 days of receiving EMI-137; or male participants who refuse to use two forms of contraception as defined in eligibility criteria of the protocol for at least 90 days after receiving EMI-137 with their female partner of child-bearing potential. • Poorly controlled or serious medical or psychiatric illness that, in the investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial. • Previous adverse reaction to fluorescent agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To investigate the ability of EMI-137 to produce visible fluorescence of colon cancer during laparoscopic surgery. ;Timepoint(s) of evaluation of this end point: This end point will be assessed intraoperatively only. ; Secondary Objective: 1)The ability of EMI-137 to produce visible fluorescence in nearby lymph nodes that also contain cancer. 2) To investigate the intra-operative fluorescence seen in the tumour and regional lymph nodes with the florescence seen in the bowel and lymph node specimens sent to the pathologist for examination. 3) safety profile of EMI-137 4) To explore factors which might adversely affect EMI-137 fluorescence detection of colon cancer. To assess patient and operative factors that are/or appear to be affecting the diagnostic yield of EMI-137 5) To compare and contrast the fluorescence seen in normal tissue with that seen in colon cancer and in regional lymph nodes containing cancer. 6) To use methods of fluorescent microscopy to examine tissue specimens obtained with the intra-operative appearance of the tumour with EMI-137. 7) To compare the EMI-137 fluorescence seen in normal healthy tissue against that seen in the tumour. This is referred to as noise to signal ratio. ;Main Objective: The aim of this study is to investigate the ability of a fluorescent medical product called EMI-137 to produce visible fluorescence in colon cancer during laparoscopic (keyhole) surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer. 2) To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens. 3) To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histopathological evidence of metastasis. 4) To explore the tumour (signal) to background (noise) florescence 5) Investigation of the safety profile of EMI-137 6) Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer. 7) Study of in vivo imaging compared against ex vivo fluorescent detection. ;Timepoint(s) of evaluation of this end point: Trial involvement will cease 30 days after surgery. All endpoints will be assessed within 30 days of surgery. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Research Fellow
The University of Leeds
Outcome results
None listed