INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04574427

Acronym

INFLUENCE

Enrollment

Registered

2020-10-05

Start date

2019-11-13

Completion date

2020-11-14

Last updated

2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Penile Cancer

Keywords

surgery, fluorescent c-met tracer, penile, tongue

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
tumour visualization by means of c-MET targeted fluores-cence imaging	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.

Secondary

Measure	Time frame	Description
Lymph node visualization by means of c-MET targeted fluores-cence imaging	peri-operative	Detection and visualization of lymph node metastases in penile and tongue tumour patients
Dysplasia or Cis by means of c-MET targeted fluores-cence imaging	Peri-operative	Identification of dysplasia or carcinoma in situ in penile and tongue tumours.

Countries

Netherlands

Outcome results