EMI-137 in Laparoscopic Colonic Resections

• Status: Unknown status
• Trial end date: 2019-03-14
• Target enrollment: 0
• Participant gender: All

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 recruited to the trial. Participants will receive a single intravenous dose of the IMP - EMI-137 1 to 3 hours before surgery. The ability of EMI-137 to produce visible intra-operative fluorescence of primary colon cancer and lymph node metastases will be explored and evaluated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leeds
• Collaborator: Edinburgh Molecular Imaging Ltd

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.