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

Sponsor

The Netherlands Cancer Institute (Other)

Overall Status

Suspended

CT.gov ID

NCT04574427

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Penile Cancer

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

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 13, 2019

Anticipated Primary Completion Date :

Nov 13, 2020

Anticipated Study Completion Date :

Nov 13, 2020

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Netherlands Cancer Institute / Antoni van Leeuwenhoek	Amsterdam	Noord-Holland	Netherlands	1066CX

Sponsors and Collaborators

The Netherlands Cancer Institute

Investigators

Principal Investigator: Baris Karakullukcu, MD, PhD, The Netherlands Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Netherlands Cancer Institute

ClinicalTrials.gov Identifier:

NCT04574427

Other Study ID Numbers:

N19IFC

First Posted:

Oct 5, 2020

Last Update Posted:

Oct 5, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Netherlands Cancer Institute

surgery

fluorescent c-met tracer

penile

tongue

Additional relevant MeSH terms:

Penile Neoplasms

Study Results

No Results Posted as of Oct 5, 2020