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    Summary
    EudraCT Number:2012-000424-18
    Sponsor's Protocol Code Number:ICTUC/32/2012
    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:2012-09-20
    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 number2012-000424-18
    A.3Full title of the trial
    A study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative lymphatic imaging and sentinel lymph node identification during standard surgical resection for colonic cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lymphatic mapping for sentinel node identification
    A.3.2Name or abbreviated title of the trial where available
    Lymphatic mapping for sentinel node identification and analysis
    A.4.1Sponsor's protocol code numberICTUC/32/2012
    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 SponsorImperial College London
    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 supportSt. Mark's Foundation, St. Mark's Hospital and Academic Institute
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt. Mark's Hospital and Academic Institute, North West London Hospitals Trust
    B.5.2Functional name of contact pointMiss Adela Brigic
    B.5.3 Address:
    B.5.3.1Street AddressWatford Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeHA1 3UJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02082354016
    B.5.6E-mailadela.brigic@gmail.com
    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 Yes
    D.2.1.1.1Trade name ICG-Pulsion
    D.2.1.1.2Name of the Marketing Authorisation holderPULSION Medical Systems AG
    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 nameIndocyanine Green (ICG)
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIndocyanine Green (ICG)
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Bowel cancer
    E.1.1.1Medical condition in easily understood language
    Bowel cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to determine whether the first (sentinel) lymph nodes in the drainage pathway of a colonic tumour can be detected at the time of surgery using a new technique. The detection method is to inject a fluorescent dye (indocyanine green) into the colon adjacent to the tumour. The dye will then be seen as it fluoresces in the light from the near infrared spectrum that can be used at the time of the laparoscopic (keyhole) surgery. An endoscope is placed in the colon (colonoscopy) during surgery and the tracer fluorescent agent is injected around the tumour. The mesentery in which the lymph nodes draining the tumour are located will then be examined by laparoscopy and it is expected that fluorescence will be identified within approximately 5 minutes of the injection. The first lymph node or nodes that take up the fluorescent dye will then be marked by placing a clip or a stitch by them. After the surgery has been completed and colon removed, all lymph nodes w
    E.2.2Secondary objectives of the trial
    • To assess the extent to which that the tumour-bearing status of SLN(s) identified corresponds with lymph node status as assessed by standard methods (pathological examination of excised nodes using H&E and immunohistochemistry) • To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must fulfil all of the following criteria. 1) Patients willing and able to give informed consent for participation in the study 2) Patients willing and able to comply with the study procedures 3) Male or Female, aged 18 years or above 4) Patients diagnosed with T1 or T2 colonic neoplasia on preoperative staging and require laparoscopic surgical excision 5) If female, a negative pregnancy test for women of childbearing potential prior to surgery 6) Patients who have clinically acceptable laboratory results pre-operatively with serum creatinine of <110 mg/dL
    E.4Principal exclusion criteria
    1) Patients diagnosed with T3 or T4 disease on preoperative imaging 2) A patient who is pregnant, lactating or planning pregnancy during the course of the study 3) Allergy to any of the compounds being used for lymphatic mapping including Indocyanine green or sodium iodide 4) Patients with hyperthyroidism or those with thyroid adenomas 5) Patients with renal insufficiency (serum creatinine of >110 mg/dL) 6) Patients in whom the use of ICG is contraindicated including development of adverse events when previously or presently administered 7) Previous allergic reaction to shellfish
    E.5 End points
    E.5.1Primary end point(s)
    To establish whether it is possible to identify the first order draining mesocolic lymph nodes (sentinel lymph node(s) (SLNs) in patients with suspected T1 and T2 colonic cancer, using ICG, a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As it is a feasibility study and we are recruiting a small number of patients, evaluation of data will not commence untill the last patient has undergone surgery.
    E.5.2Secondary end point(s)
    • Sensitivity and specificity of tumour-bearing status of SLN(s) as a measure of lymph node status when assessed by standard techniques. • Frequency and tumour-bearing status of aberrant SLN(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As it is a feasibility study and we are recruiting a small number of patients, evaluation of data will not commence untill the last patient has undergone surgery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 No
    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
    Definition of the trial is: Last Patient Last Data (LPLD) item
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    This is a feasibility trial and active patient participation in this study concludes with the end of the operation, therefore this is not applicable. Ongoing care or support, in addition to the standard follow-up, is not necessary but can be provided if the patient should request it. Data collection however will be performed on the first postoperative day as well as the at 4 weeks after surgery through a telephone interview in order to capture any adverse events after the procedure.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-26
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