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    Summary
    EudraCT Number:2016-003128-22
    Sponsor's Protocol Code Number:1.1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-08-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003128-22
    A.3Full title of the trial
    Intraoperative imaging of colon cancer using a fluorescent peptide (EMI-137) against the c-Met receptor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging colon cancer during laparoscopic "keyhole" surgery with EMI-137.
    A.4.1Sponsor's protocol code number1.1
    A.5.4Other Identifiers
    Name:Sponsor's NumberNumber:GS16/87090
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe University of Leeds
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe University of Leeds
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe University of Leeds
    B.5.2Functional name of contact pointClinical Research Fellow
    B.5.3 Address:
    B.5.3.1Street AddressOffice 7.5, Level 7, Clinical Sciences Building, St James' University Hospital
    B.5.3.2Town/ cityleeds
    B.5.3.3Post codeLS9 7TF
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailgemmaarmstrong@doctors.org.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEMI-137
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colon cancer
    E.1.1.1Medical condition in easily understood language
    Bowel cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate the ability of a fluorescent medical product called EMI-137 to produce visible fluorescence in colon cancer during laparoscopic (keyhole) surgery.
    E.2.2Secondary objectives of the trial
    1)The ability of EMI-137 to produce visible fluorescence in nearby lymph nodes that also contain cancer.
    2) To investigate the intra-operative fluorescence seen in the tumour and regional lymph nodes with the florescence seen in the bowel and lymph node specimens sent to the pathologist for examination.
    3) safety profile of EMI-137
    4) To explore factors which might adversely affect EMI-137 fluorescence detection of colon cancer. To assess patient and operative factors that are/or appear to be affecting the diagnostic yield of EMI-137
    5) To compare and contrast the fluorescence seen in normal tissue with that seen in colon cancer and in regional lymph nodes containing cancer.
    6) To use methods of fluorescent microscopy to examine tissue specimens obtained with the intra-operative appearance of the tumour with EMI-137.
    7) To compare the EMI-137 fluorescence seen in normal healthy tissue against that seen in the tumour. This is referred to as noise to signal ratio.
    E.2.3Trial contains a sub-study No
    E.3Principal 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).
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    To investigate the ability of EMI-137 to produce visible fluorescence of colon cancer during laparoscopic surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This end point will be assessed intraoperatively only.
    E.5.2Secondary end point(s)
    1) To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
    2) To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens.
    3) To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histopathological evidence of metastasis.
    4) To explore the tumour (signal) to background (noise) florescence
    5) Investigation of the safety profile of EMI-137
    6) Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer.
    7) Study of in vivo imaging compared against ex vivo fluorescent detection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Trial involvement will cease 30 days after surgery. All endpoints will be assessed within 30 days of surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Trial specific post-operative care will not deviate from standard operative care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-29
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