Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
研究概览
简要总结
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.
详细描述
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 colon cancer and lymph node metastases.
The aim of this study is to investigate the ability of a fluorescent imaging agent - EMI-137 to produce visible fluorescence in colon cancer during laparoscopic surgery. EMI-137 consists of a cyanine dye coupled to a c-Met targeted peptide. It is supplied by Edinburgh Molecular Imaging Ltd. Colon cancer along with several other types of cancer over-express and/or show upregulation of the c-Met receptor. We anticipate, EMI-137 will accumulate in the tumour and any lymph nodes metastases when administered intravenously 1 to 3 hours before laparoscopic colonic resection surgery. The intravenous administration of EMI-137 may allow real-time intra-operative visualisation of colon cancer and any metastatic lymph nodes, aiding the safe and accurate resection of the tumour.
In total 10 patients will be recruited. Patients will have a diagnosis of primary colon adenocarcinoma, confirmed on biopsy or on radiological imaging, and will have been discussed at the colorectal cancer MDT meeting. Imaging will have been performed less than 8 weeks prior to surgery. Patients will be fit for surgical resection of the primary cancer. They may have suspected or confirmed distant metastatic disease. The planned procedure may be of palliative or curative intent. The anticipated recruitment period is six (6) months with one (1) month of trial follow-up.
Participants will receive written and verbal information, and allowed at least 24 hours to consider their participation in the trial. Participating patients will provide written, informed consent. Pre-operative patient demographics will be collected, including gender, age, BMI, baseline FBC, U&Es, LFTs and clotting profile, co-morbidities, ASA grade, and medication. All patients will undergo routine preoperative assessment, to include colonic imaging, and staging CT scan of chest, abdomen and pelvis. The planned procedure and radiological staging will be documented.
Patients will be administered an intravenous bolus of EMI-137 at a dose of between 0.02mg/kg to 0.13mg/kg EMI-137 2.5 hours (range 1 to 3 hours) prior to the surgical procedure start time (this refers to expected "knife to skin time"). The maximum dose will be 0.13mg/mg per patient for the total operative period. The time of administration will be recorded. Patients will be closely monitored for any adverse reactions to the medicinal product (as per schedule below).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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-
- •(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).
排除标准
- •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-
- •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.
研究组 & 干预措施
EMI-137
Ten participants to receive the IMP - EMI-137 1 to 3 hours before laparoscopic colonic resection surgery. Dose range 0.02mg/kg to 0.13mg/kg will be administered.
干预措施: EMI-137 (Drug)
结局指标
主要结局
To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
时间窗: 6 months
The ability of EMI-137 to detect colon cancer will be measured using the semi-quantitative descriptive terms of; highly fluorescent, mildly fluorescent and isofluorescent to background. The number of primary tumours highly or mildly fluorescent will be used to assess the success of EMI-137 as an imaging agent. The opinion of the senior operative surgeon performing the cases will also be taken in to consideration when appraising the efficacy of EMI-137.
次要结局
- Study of in vivo imaging compared against ex vivo fluorescent detection(6 months)
- Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer.(6 months)
- Investigation of the safety profile of EMI-137(7 months)
- To investigate of the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.(6 months)
- To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens.(6 months)
- To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histological evidence of metastasis.(6 months)
- To explore the tumour (signal) to background (noise) florescence(6 months)
研究者
David Jayne
Consultant Colorectal Surgeon
University of Leeds