Image Guided Penile Cancer Surgery

NCT05376202 | Completed Phase 1

• 1 other identifier: 202000333
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The main treatment modality for Penile Squamous Cell Carcinoma (PSCC) is surgery with curative intent. In organ sparing surgery a tumor-positive margin of up to 36% exist. Tumor-positive surgical margins are an independent risk factor for local recurrence, which has been reported to be up to 18%. Tumor-positive margins always lead to extra, penile sparing surgery, which leads to longer hospitalization, higher exposure to anesthetic interventions and a worse psychological outcome. Currently, no intraoperative imaging technique that provides real time feedback for resection margins exists in PSCC. Molecular fluorescence-guided Surgery (MFGS) using targeted near-infrared (NIR) optical contrast agents like for example Cetuximab-800CW is a promising technique to accommodate this need. Epidermal Growth Factor Receptor (EGFR) is overexpressed in PSCC and has safely and successfully been used as target for molecular imaging, particularly for assessment for tumor margins in head and neck squamous cell carcinoma (ICON study, UMCG1).

Conditions

Penile Cancer; Margin Assessment

Outcome Measures

Primary Outcomes (1)

• Phase 1: Compare the spot to background ratio for tumor positive and tumor negative margins.

  The main purpose is to establish the intraoperative use of cetuximab-800CW as a reliable marker for residual tumor in resection margins after surgical removal of PSCC. The objective is to establish the feasibility of cetuximab-800CW fluorescence at the dose of 75/15 mg predose/dose combination as a marker for a tumor positive resection by comparing the spot to background ratios for tumor positive and tumor negative margins. A tumor to background ratio of \>2.0 is aspired.

  2 years

Secondary Outcomes (1)

• Quantification of sensitivity and positive predictive value of cetuximab-800CW in PSCC

  2 years

Study Arms (1)

Phase 1: 75mg Cetuximab and 15mg Cetuximab-IRDye800CW

EXPERIMENTAL

Patients receive 75mg of Cetuximab, followed by 15mg Cetuximab-IRDye800CW I.V. two days prior to surgery.

Drug: Cetuximab-IRDye800CW

Interventions

Cetuximab-IRDye800CW DRUG

Patients will receive 75mg Cetuximab followed by 15mg Cetuximab-IRDye800CW two days prior to surgery

Phase 1: 75mg Cetuximab and 15mg Cetuximab-IRDye800CW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy confirmed diagnosis of primary or recurrent PSCC and scheduled to undergo surgical resection of primary or recurrent tumor with or without (sentinel) lymph node procedure as decided by the Urology Department of the UMCG.
• Age ≥ 18 years
• Written informed consent
• Adequate potential for follow-up

You may not qualify if:

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent
• Concurrent uncontrolled medical conditions
• Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
• Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible
• Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina
• Inadequately controlled hypertension with or without current antihypertensive medications
• History of infusion reactions to cetuximab or other monoclonal antibody therapies
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
• Lab values that in the opinion of the primary surgeon would prevent surgical resection
• Patients receiving Class Ia (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
• Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE)
• Life expectancy \< 12 weeks
• Karnofsky performance status \< 70%

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Penile Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 17, 2022
• Study Start: March 7, 2022
• Primary Completion: May 1, 2023
• Study Completion: April 14, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

NL (1)