Colonic CancerPhase 2NCT03360461
EMI-137 in Laparoscopic Colonic Resections
A Phase 2 study testing EMI-137 in people with Colonic Cancer and Metastasis to Lymph Node, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colonic Cancer, Metastasis to Lymph Node
- What is being tested?
- EMI-137
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 14 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients with a diagnosis of colonic cancer (the disease can be of any radiological TMN stage and be located anywhere from the caecum up to but not including the rectosigmoid junction)
- 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.
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- 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 Injection.
- Pre-menopausal female participants of child-bearing potential who agree to employ two method of contraception (as defined in eligibility criteria of the protocol) 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 partner of child-bearing potential who agree to use two forms of contraception (as defined in section 8.2) 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) or has undergone documented bilateral oophorectomy and/or hysterectomy).
Who cannot join
- 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).
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- Pregnant and breastfeeding woman.
- Pre-menopausal woman planning to become pregnant within 90 days of receiving EMI-137; or pre-menopausal woman 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 section 8.2 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St James' University Hospital Trust
Leeds, LS8 1RN
About this study
Official title: Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor
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.
Read the 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.
- Conditions
- Colonic Cancer, Metastasis to Lymph Node
- Being tested
- EMI-137
- Medical subject headings
- Colonic Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMI-137Drug
EMI-137 - a fluorescent c-Met receptor targeted peptide
| Study group | Role | What they receive |
|---|---|---|
| EMI-137 | Experimental | 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. Receives: Drug: EMI-137 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
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.
Measured: 6 months
Secondary outcomes (7)
To investigate of the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
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.
Measured: 6 months
To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens.
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.
Measured: 6 months
To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histological evidence of metastasis.
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.
Measured: 6 months
To explore the tumour (signal) to background (noise) florescence
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.
Measured: 6 months
Investigation of the safety profile of EMI-137
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.
Measured: 7 months
Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer.
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.
Measured: 6 months
Study of in vivo imaging compared against ex vivo fluorescent detection
- 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start14 Feb 2018
- Primary completion14 Feb 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colonic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre stage IIa developmental study, Open label, single arm, non-randomised feasibility study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Edinburgh Molecular Imaging Ltd
- Responsible party
- Principal investigator, David Jayne, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360461
- Sponsor's protocol ID
- GS16/87090
- Status last verified
- May 2024
- First submitted
- 7 Nov 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burggraaf J, Kamerling IM, Gordon PB, Schrier L, de Kam ML, Kales AJ, Bendiksen R, Indrevoll B, Bjerke RM, Moestue SA, Yazdanfar S, Langers AM, Swaerd-Nordmo M, Torheim G, Warren MV, Morreau H, Voorneveld PW, Buckle T, van Leeuwen FW, Odegardstuen LI, Dalsgaard GT, Healey A, Hardwick JC. Detection of colorectal polyps in humans using an intravenously administered fluorescent peptide targeted against c-Met. Nat Med. 2015 Aug;21(8):955-61. doi: 10.1038/nm.3641. Epub 2015 Jul 13.
PubMed 26168295
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Imaging of Colon Cancer Using a Fluorescent Peptide (EMI-137) Against the c-Met Receptor
- ClinicalTrials.gov ID
- NCT03360461
- Acronym / sponsor ID
- GS16/87090
- Conditions
- Colonic Cancer, Metastasis to Lymph Node
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Edinburgh Molecular Imaging Ltd
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre stage IIa developmental study, Open label, single arm, non-randomised feasibility study.
| Arm | Type | Receives |
|---|---|---|
| EMI-137 | Experimental | Drug: EMI-137Ten 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Patients with a diagnosis of colonic cancer (the disease can be of any radiological TMN stage and be located anywhere from the caecum up to but not including the rectosigmoid junction)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMI-137EMI-137 - a fluorescent c-Met receptor targeted peptide | Drug | EMI-137 |
Primary outcome
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.
7 secondary outcomes
To investigate of the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer.
Time frame: 6 months
To investigate the concordance of visible fluorescence in colon cancer with histological stage and c-MET expression in resected specimens.
Time frame: 6 months
To investigate the concordance of visible fluorescence in cancer draining lymph nodes with histological evidence of metastasis.
Time frame: 6 months
To explore the tumour (signal) to background (noise) florescence
Time frame: 6 months
Investigation of the safety profile of EMI-137
Time frame: 7 months
Exploration of systemic, operative, and patient factors, which adversely affect EMI-137 fluorescence detection of colon cancer.
Time frame: 6 months
Study of in vivo imaging compared against ex vivo fluorescent detection
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 26168295Burggraaf J, Kamerling IM, Gordon PB, Schrier L, de Kam ML, Kales AJ, Bendiksen R, Indrevoll B, Bjerke RM, Moestue SA, Yazdanfar S, Langers AM, Swaerd-Nordmo M, Torheim G, Warren MV, Morreau H, Voorneveld PW, Buckle T, van Leeuwen FW, Odegardstuen LI, Dalsgaard GT, Healey A, Hardwick JC. Detection of colorectal polyps in humans using an intravenously administered fluorescent peptide targeted against c-Met. Nat Med. 2015 Aug;21(8):955-61. doi: 10.1038/nm.3641. Epub 2015 Jul 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMI-137 in people with Colonic Cancer and Metastasis to Lymph Node, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the ability of EMI-137 to produce visible fluorescence in regional lymph nodes draining the colon cancer. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.