Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT03360461
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Patients with a diagnosis of colonic cancer (the disease can be of any radiological TMN stage and be located anywhere from the caecum up to but not including the rectosigmoid junction)
* 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 Injection.
* Pre-menopausal female participants of child-bearing potential who agree to employ two method of contraception (as defined in eligibility criteria of the protocol) 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 partner of child-bearing potential who agree to use two forms of contraception (as defined in section 8.2) 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) or has undergone documented bilateral oophorectomy and/or hysterectomy).
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 \<60 mls/min/1.73m2).
* Patients with impaired liver function (Bilirubin above institutional limits and/or ALT \>2.5x upper limit of normal).
* Pregnant and breastfeeding woman.
* Pre-menopausal woman planning to become pregnant within 90 days of receiving EMI-137; or pre-menopausal woman 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 section 8.2 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03360461
Study Brief:
Protocol Section:
NCT03360461