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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574427
Recruitment Status : Suspended (Tracer not available.)
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

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
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.

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Study Type : Observational
Estimated 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 : November 13, 2019
Estimated Primary Completion Date : November 13, 2020
Estimated Study Completion Date : November 13, 2020



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Lymph node visualization by means of c-MET targeted fluores-cence imaging [ Time Frame: peri-operative ]
    Detection and visualization of lymph node metastases in penile and tongue tumour patients

  2. Dysplasia or Cis by means of c-MET targeted fluores-cence imaging [ Time Frame: Peri-operative ]
    Identification of dysplasia or carcinoma in situ in penile and tongue tumours.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574427


Locations
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Netherlands
The Netherlands Cancer Institute / Antoni van Leeuwenhoek
Amsterdam, Noord-Holland, Netherlands, 1066CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Baris Karakullukcu, MD, PhD The Netherlands Cancer Institute
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT04574427    
Other Study ID Numbers: N19IFC
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
surgery
fluorescent c-met tracer
penile
tongue
Additional relevant MeSH terms:
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Penile Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Penile Diseases