Head and Neck CancerINFLUENCENCT04574427
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue
An observational study of Head and Neck Cancer and Penile Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Penile Cancer
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Nov 2019to 14 Nov 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.
Who may be able to join
- Written informed consent, prior to performing any protocol related procedures.
- Age ≥ 18 years at time of study entry.
- ≥ T1 penile or tongue squamous cell cancer
- Scheduled for surgical primary tumour resection
Who cannot join
- Involvement in the planning and/or conduct of the study.
- Pregnant woman
- Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
- Severe kidney insufficiency
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands Cancer Institute / Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066CX
About this study
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
Read the detailed description
This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.
- Conditions
- Head and Neck Cancer, Penile Cancer
- Keywords
- surgery, fluorescent c-met tracer, penile, tongue
- Medical subject headings
- Head and Neck Neoplasms, Penile Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
tumour visualization by means of c-MET targeted fluores-cence imaging
The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.
Measured: peri-operative
Secondary outcomes (2)
Lymph node visualization by means of c-MET targeted fluores-cence imaging
Detection and visualization of lymph node metastases in penile and tongue tumour patients
Measured: peri-operative
Dysplasia or Cis by means of c-MET targeted fluores-cence imaging
Identification of dysplasia or carcinoma in situ in penile and tongue tumours.
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start13 Nov 2019
- Primary completion13 Nov 2020
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baris Karakullukcu, MD, PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574427
- Sponsor's protocol ID
- N19IFC
- Acronym
- INFLUENCE
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2020
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue
- ClinicalTrials.gov ID
- NCT04574427
- Acronym / sponsor ID
- INFLUENCE / N19IFC
- Conditions
- Head and Neck Cancer, Penile Cancer
- Keywords
- surgery, fluorescent c-met tracer, penile, tongue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 5 Oct 2020 (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.
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
Detailed description
This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.
Key inclusion criteria (4 listed)
- Written informed consent, prior to performing any protocol related procedures.
- Age ≥ 18 years at time of study entry.
- ≥ T1 penile or tongue squamous cell cancer
- Scheduled for surgical primary tumour resection
Key exclusion criteria (4 listed)
- Involvement in the planning and/or conduct of the study.
- Pregnant woman
- Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
- Severe kidney insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tumour visualization by means of c-MET targeted fluores-cence imaging
Time frame: peri-operative
The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.
2 secondary outcomes
Lymph node visualization by means of c-MET targeted fluores-cence imaging
Time frame: peri-operative
Dysplasia or Cis by means of c-MET targeted fluores-cence imaging
Time frame: Peri-operative
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 19 Oct 2022.
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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.
Baris Karakullukcu, MD, PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Penile Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 4 inclusion and 4 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 19 Oct 2022. 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 Netherlands. 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.
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?
tumour visualization by means of c-MET targeted fluores-cence imaging (time frame: peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022.