Intra-operative evaluation of a novel tracer in penile and tongue cancer

Phase 1

• Conditions: Penile cancer and tongue cancer; MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: HLT Classification code 10034300 Term: Penile neoplasms malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003022-24-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 20

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The feasibility of intraoperative visualization of primary penile and tongue tumours using c-Met-based receptor-mediated fluorescence imaging.;<br> Secondary Objective: - Detection and visualization of lymph node metastases in penile and tongue tumour patients <br> - Identification of dysplasia or carcinoma in situ in penile and tongue tumours.<br> - Toxicity by CTCAE-NCI V4<br> ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: one week after procedure

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Detection and visualization of lymph node metastases in penile and tongue tumour patients. <br> - Identification of dysplasia or carcinoma in situ in penile and tongue tumours.<br> ;Timepoint(s) of evaluation of this end point: one week after procedure