EMI-137 in Laparoscopic Colonic Resections
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|ClinicalTrials.gov Identifier: NCT03360461|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : October 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Colonic Cancer Metastasis to Lymph Node||Drug: EMI-137||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-centre stage IIa developmental study, Open label, single arm, non-randomised feasibility study.|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor|
|Actual Study Start Date :||February 14, 2018|
|Estimated Primary Completion Date :||February 14, 2019|
|Estimated Study Completion Date :||March 14, 2019|
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.
EMI-137 - a fluorescent c-Met receptor targeted peptide
- To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer. [ Time Frame: 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.
- To investigate of the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer. [ Time Frame: 6 months ]The ability of EMI-137 to detect metastatic lymph nodes will be measured using the semi-quantitative descriptive terms of; highly fluorescent, mildly fluorescent and isofluorescent to background. The number of lymph nodes deemed to be highly or mildly fluorescent intraoperatively will be used to measure 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.
- To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens. [ Time Frame: 6 months ]The resected specimen(s) will undergo thorough standard and trial-specific histopathological assessment. Cryosections will be taken from fresh frozen samples and analysed by fluorescent microscopy. The intraoperative fluorescence obtained will have been graded as either; highly fluorescent, mildly fluorescent or isofluorescent. The tumour stage will be ascertained and compared against the pre-operative radiological stage and the intraoperative fluorescence seen. High concordance will be a measure of success. The degree of fluorescence obtained may also be compared against the level of c-Met expression and the morphological and functional characteristics of the tumour. All comparisons will be made against the gold standard- standard histopathological assessment of the tumour, lymph nodes and the ascribed pathological stage of the tumour.
- To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histological evidence of metastasis. [ Time Frame: 6 months ]The pre-operative predicted lymph node status will be compared against the pathological lymph node status and the intra-operative lymph node appearance with the administration of EMI-137. Step sectioning and cytokeratin staining of fluorescent nodes will be performed if metastatic disease is not identified during standard histopathological analysis. High concordance between the intraoperative appearance and the final TMN lymph node status will be used as a measure of success.
- To explore the tumour (signal) to background (noise) florescence [ Time Frame: 6 months ]The background (noise) appearance of nearby structures will be compared against the tumour and/lymph node (signal) in each case. High contrast between structures (high signal to noise ratio) will be used to measure the success of EMI-137 as an imaging agent. Factors likely to be negatively influencing the tumour to signal ratio will be evaluated and used to modify any further larger trials with EMI-137.
- Investigation of the safety profile of EMI-137 [ Time Frame: 7 months ]The number of adverse events (AE/AR/SAE/SUSAR) arising from the administration of EMI-137 or the related surgery will be measured and reported.
- Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer. [ Time Frame: 6 months ]Baseline demographic data will be analysed against the intraoperative and pathological results to determine any patient or surgical factors that negatively influence intra-operative visualisation with EMI-137. For example, Body Mass Index and tumour stage will be correlated to intraoperative results to determine possible adverse relationship.
- Study of in vivo imaging compared against ex vivo fluorescent detection [ Time Frame: 6 months ]8. Fluorescent microscopy of fresh frozen biopsies from the resected specimen will be analysed for fluorescence. This will be compared and contrasted against the intra-operative appearance of the tumour and draining lymph nodes with EMI-137. The results will compared against the gold standard - histopathological assessment of tumour characteristics and TMN (tumour, node and metastases) stage for concordance. High concordance will be used to measure the success of EMI-137 as an imaging agent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360461
|Contact: David G Jayne, MD||0113 206 email@example.com|
|Contact: Gemma R Armstrong, MBChB||0113 343 firstname.lastname@example.org|