EMI-137 in Laparoscopic Colonic Resections

NCT03360461 | Completed Phase 2

• 1 other identifier: GS16/87090
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colonic Cancer; Metastasis to Lymph Node

Outcome Measures

Primary Outcomes (1)

• To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.

  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.

  6 months

Secondary Outcomes (7)

• 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

• Investigation of the safety profile of EMI-137

  7 months

Study Arms (1)

EMI-137

EXPERIMENTAL

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.

Drug: EMI-137

Interventions

EMI-137 DRUG

EMI-137 - a fluorescent c-Met receptor targeted peptide

EMI-137

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead
• Edinburgh Molecular Imaging Ltd: collaborator

Study Sites (1)

St James' University Hospital Trust

Leeds, LS8 1RN, United Kingdom

Location

Related Publications (1)

• Burggraaf J, Kamerling IM, Gordon PB, Schrier L, de Kam ML, Kales AJ, Bendiksen R, Indrevoll B, Bjerke RM, Moestue SA, Yazdanfar S, Langers AM, Swaerd-Nordmo M, Torheim G, Warren MV, Morreau H, Voorneveld PW, Buckle T, van Leeuwen FW, Odegardstuen LI, Dalsgaard GT, Healey A, Hardwick JC. Detection of colorectal polyps in humans using an intravenously administered fluorescent peptide targeted against c-Met. Nat Med. 2015 Aug;21(8):955-61. doi: 10.1038/nm.3641. Epub 2015 Jul 13.

  PMID: 26168295 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Colorectal Surgeon

Model Details: Single-centre stage IIa developmental study, Open label, single arm, non-randomised feasibility study.

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: December 4, 2017
• Study Start: February 14, 2018
• Primary Completion: February 14, 2020
• Study Completion: March 14, 2020
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)