Clinical Trial Results:
Intraoperative imaging of colon cancer using a fluorescent peptide (EMI-137) against the c-Met receptor
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Summary
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EudraCT number |
2016-003128-22 |
Trial protocol |
GB |
Global end of trial date |
29 Aug 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jun 2020
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First version publication date |
28 Jun 2020
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Other versions |
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Summary report(s) |
EMI-137 Final report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS16/87090
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Sponsor's Number: GS16/87090 | ||
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Sponsors
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Sponsor organisation name |
University of Leeds
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Sponsor organisation address |
Worsley Building, Leeds, United Kingdom, LS2 9JT
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Public contact |
Clinical Research Fellow, The University of Leeds, gemmaarmstrong@doctors.org.uk
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Scientific contact |
Clinical Research Fellow, The University of Leeds, gemmaarmstrong@doctors.org.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Aug 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Aug 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main 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.
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Protection of trial subjects |
Patients will be identified via the colorectal cancer MDT and approached to participate in the study. The research team will ensure that recruited patients meet all of the eligibility criteria. Patients will receive written and verbal information, and allowed at least 24 hours to consider their participation. Participating patients will provide written, informed consent. Consent will be obtained by an appropriately delegated member of team, any time up to the morning of surgery, prior to administration of the IMP. It is permissible to take trial specific consent at the same time as consent for the planned colonic resection. The patient’s general practitioner will be informed of their involvement. 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.
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Background therapy |
Colorectal cancer (CRC) is the fourth most common malignancy in the UK. In 2013, 41,112 cases were diagnosed. CRC is strongly related to age, with nearly 60% of cases diagnosed in patients over the age of 70 years. CRC continues to be the second highest cause of cancer related mortality in the UK, accounting for 10% of all cancer related deaths [1]. In the most deprived social groups this figure is greater. CRC mortality is 30% higher in males from the poorest areas than in their age-standardised counterparts from the least deprived areas. CRC poses significant disease burden, with the NHS continuing to see a year on year rise in cases, often in an older population with significant co-morbidities [1]. The anatomical distribution of CRC varies slightly between the genders and with age. However, there is a left-sided predominance, with over 30% of CRC seen in the rectum/rectosigmoid junction and a further quarter in the sigmoid or descending colon [1]. Survival rates in CRC are strongly correlated to the stage at diagnosis. One year survival data from 2012 shows 98% of patients presenting with stage I disease were alive after one year compared to only 46% with stage IV disease [2]. Long-term survival can usually only be achieved with curative resection. This involves segmental colectomy and en-bloc resection of the draining lymph node field. Currently there is significant variance of opinion regarding the radicality of resection and, in particular the extent of lymphadenectomy [3]. A method of accurately visualising the tumour and any associated metastatic lymph nodes in real-time would be invaluable for intra-operative decision making, allowing the surgeon to tailor the radicality of resection to the stage of disease. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 9
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Worldwide total number of subjects |
9
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EEA total number of subjects |
9
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
The first patient was recruited to the trial on 14th February 2018. Patients suitable for participation in this study were identified via the local MDT meeting. They were approached during their routine clinic with verbal & written info about the trial. Patients who fulfilled the eligibility criteria were asked to give informed written consent. | |||||||||
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Pre-assignment
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Screening details |
patients were screened as per the eligibility criteria listed in the protocol, prior to surgery. | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Baseline Arm | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
EMI-137
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
EMI-137 will be administrated by intravenous bolus at a dose of 0.02mg/kg to 0.13mg/kg body weight. The expected trial dose is 0.13mg/kg. This may be adjusted during the course of the clinical trial with evolving results from background to signal ratio.
No placebo or comparative drug will be used.
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Arm title
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End Data | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
EMI-137
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
EMI-137 will be administrated by intravenous bolus at a dose of 0.02mg/kg to 0.13mg/kg body weight. The expected trial dose is 0.13mg/kg. This may be adjusted during the course of the clinical trial with evolving results from background to signal ratio.
No placebo or comparative drug will be used.
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Baseline Arm
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Reporting group description |
- | ||
Reporting group title |
End Data
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Reporting group description |
- | ||
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End point title |
Tumour fluorescence [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
measured at time of surgery
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please see attached End of Trial Report for information on all statistical analysis performed. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
All participants safety data was reviewed at every trial visit.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4.0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Please see attached End of Trial Report for all safety data. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Dec 2017 |
Introduction of the Union for International Cancer Control TNM v8 classification system Tumour Node Metastasis (TNM) v8.0 classification system on 1st January 2018 at LTHT necessitated a substantial amendment to the trial protocol. Regulatory approval was granted for this prior to trial commencement by REC and MHRA on 5th January and 10th January 2018 respectively. |
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29 Jan 2018 |
The Investigator Brochure (IB) and Investigational Medicinal Product Dossier (IMPD) were updated by the Industrial Partner and drug supplier Edinburgh Molecular Imaging Ltd (EM Ltd) to incorporate batch re-test results and new safety information discovered. This facilitated shelf-life extension of the EMI-137 batch supplied to LTHT. MHRA approved the first substantial amendment to these supporting documents on 25th March 2018. |
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15 Feb 2019 |
The expected recruitment period was extended by a further six months. This was approved on 15th February 2019. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
