Status:
COMPLETED
EMI-137 in Laparoscopic Colonic Resections
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
Edinburgh Molecular Imaging Ltd
Conditions:
Colonic Cancer
Metastasis to Lymph Node
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study. Ten adult participants with a diagnosis of colon adenocarcinoma undergoing laparoscopic colonic will be re...
Detailed Description
EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study to explore and evaluate the ability of EMI-137 to produce visible intra-operative fluorescence of primary co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03360461
Start Date
February 14 2018
End Date
March 14 2020
Last Update
May 8 2024
Active Locations (1)
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1
St James' University Hospital Trust
Leeds, United Kingdom, LS8 1RN