Imaging colon cancer during laparoscopic keyhole surgery with EMI-137.

Phase 1

• Conditions: Colon cancer; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2016-003128-22-GB
• Lead Sponsor: The University of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

•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) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified