Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
Study NCT ID:
NCT03360461
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2017-11-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMI-137 in Laparoscopic Colonic Resections
Sponsor:
University of Leeds
Organization:
Study Overview
Official Title:
Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
EMI-137 in laparoscopic colonic resections is a single-centre stage IIa developmental study to explore and evaluate the ability of EMI-137 to produce visible intra-operative fluorescence of primary colon cancer and lymph node metastases.
The aim of this study is to investigate the ability of a fluorescent imaging agent - EMI-137 to produce visible fluorescence in colon cancer during laparoscopic surgery. EMI-137 consists of a cyanine dye coupled to a c-Met targeted peptide. It is supplied by Edinburgh Molecular Imaging Ltd. Colon cancer along with several other types of cancer over-express and/or show upregulation of the c-Met receptor. We anticipate, EMI-137 will accumulate in the tumour and any lymph nodes metastases when administered intravenously 1 to 3 hours before laparoscopic colonic resection surgery. The intravenous administration of EMI-137 may allow real-time intra-operative visualisation of colon cancer and any metastatic lymph nodes, aiding the safe and accurate resection of the tumour.
In total 10 patients will be recruited. Patients will have a diagnosis of primary colon adenocarcinoma, confirmed on biopsy or on radiological imaging, and will have been discussed at the colorectal cancer MDT meeting. Imaging will have been performed less than 8 weeks prior to surgery. Patients will be fit for surgical resection of the primary cancer. They may have suspected or confirmed distant metastatic disease. The planned procedure may be of palliative or curative intent. The anticipated recruitment period is six (6) months with one (1) month of trial follow-up.
Participants will receive written and verbal information, and allowed at least 24 hours to consider their participation in the trial. Participating patients will provide written, informed consent. 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.
Patients will be administered an intravenous bolus of EMI-137 at a dose of between 0.02mg/kg to 0.13mg/kg EMI-137 2.5 hours (range 1 to 3 hours) prior to the surgical procedure start time (this refers to expected "knife to skin time"). The maximum dose will be 0.13mg/mg per patient for the total operative period. The time of administration will be recorded. Patients will be closely monitored for any adverse reactions to the medicinal product (as per schedule below).
The surgical procedure will be as per surgeon preference but must include laparoscopic surgery. The procedure must use a Near Infra-Red laparoscopic system such as the Karl Storz® endoscopic fluorescence imaging systems. It will be used to evaluate the colon cancer and regional lymph nodes under both white and red light. The presence of fluorescence within the primary cancer and any draining lymph nodes will be recorded relative to background fluorescence. The intensity of fluorescence will be recorded semi-quantitatively as: highly fluorescent, mildly fluorescent or isofluorescent to background. Mobilisation of structures to permit visualisation of the cancer and lymph nodes is permissible as long as the oncological principles of the operation are not compromised. Any fluorescent lymph nodes will be marked with a surgical clip (Ligaclip) to allow subsequent histopathological identification.
Postoperative care will be as routinely provided. Patients will be monitored for any adverse effects related to the medicinal product. Any adverse reactions as defined in the protocol below will be reported to the CI, clinical trial team, the industrial sponsor and where necessary, the appropriate regulatory bodies.
The histopathologists involved in the trial will examine the specimen using routine and trial specific histopathological techniques. The fluorescences obtained from the fresh frozen specimens will be appraised using the same semi-quantitative scale used intraoperatively; highly fluorescent, mildly fluorescent and isofluorescent. The tumour stage will be ascertained and compared against the pre-operative radiological stage. 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. Separate fresh tissue samples (unfixed cancer and normal mucosal tissue) will be taken, if accessible, and stored in a HTA-approved tissue bank.
Patients will be followed up as per routine practice. All patients will be reviewed in a colorectal clinic between 2 and 3 weeks following discharge, at which point their involvement in the study will cease.
The aim of this study is to investigate the ability of a fluorescent imaging agent - EMI-137 to produce visible fluorescence in colon cancer during laparoscopic surgery. EMI-137 consists of a cyanine dye coupled to a c-Met targeted peptide. It is supplied by Edinburgh Molecular Imaging Ltd. Colon cancer along with several other types of cancer over-express and/or show upregulation of the c-Met receptor. We anticipate, EMI-137 will accumulate in the tumour and any lymph nodes metastases when administered intravenously 1 to 3 hours before laparoscopic colonic resection surgery. The intravenous administration of EMI-137 may allow real-time intra-operative visualisation of colon cancer and any metastatic lymph nodes, aiding the safe and accurate resection of the tumour.
In total 10 patients will be recruited. Patients will have a diagnosis of primary colon adenocarcinoma, confirmed on biopsy or on radiological imaging, and will have been discussed at the colorectal cancer MDT meeting. Imaging will have been performed less than 8 weeks prior to surgery. Patients will be fit for surgical resection of the primary cancer. They may have suspected or confirmed distant metastatic disease. The planned procedure may be of palliative or curative intent. The anticipated recruitment period is six (6) months with one (1) month of trial follow-up.
Participants will receive written and verbal information, and allowed at least 24 hours to consider their participation in the trial. Participating patients will provide written, informed consent. 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.
Patients will be administered an intravenous bolus of EMI-137 at a dose of between 0.02mg/kg to 0.13mg/kg EMI-137 2.5 hours (range 1 to 3 hours) prior to the surgical procedure start time (this refers to expected "knife to skin time"). The maximum dose will be 0.13mg/mg per patient for the total operative period. The time of administration will be recorded. Patients will be closely monitored for any adverse reactions to the medicinal product (as per schedule below).
The surgical procedure will be as per surgeon preference but must include laparoscopic surgery. The procedure must use a Near Infra-Red laparoscopic system such as the Karl Storz® endoscopic fluorescence imaging systems. It will be used to evaluate the colon cancer and regional lymph nodes under both white and red light. The presence of fluorescence within the primary cancer and any draining lymph nodes will be recorded relative to background fluorescence. The intensity of fluorescence will be recorded semi-quantitatively as: highly fluorescent, mildly fluorescent or isofluorescent to background. Mobilisation of structures to permit visualisation of the cancer and lymph nodes is permissible as long as the oncological principles of the operation are not compromised. Any fluorescent lymph nodes will be marked with a surgical clip (Ligaclip) to allow subsequent histopathological identification.
Postoperative care will be as routinely provided. Patients will be monitored for any adverse effects related to the medicinal product. Any adverse reactions as defined in the protocol below will be reported to the CI, clinical trial team, the industrial sponsor and where necessary, the appropriate regulatory bodies.
The histopathologists involved in the trial will examine the specimen using routine and trial specific histopathological techniques. The fluorescences obtained from the fresh frozen specimens will be appraised using the same semi-quantitative scale used intraoperatively; highly fluorescent, mildly fluorescent and isofluorescent. The tumour stage will be ascertained and compared against the pre-operative radiological stage. 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. Separate fresh tissue samples (unfixed cancer and normal mucosal tissue) will be taken, if accessible, and stored in a HTA-approved tissue bank.
Patients will be followed up as per routine practice. All patients will be reviewed in a colorectal clinic between 2 and 3 weeks following discharge, at which point their involvement in the study will cease.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: