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

Intra-operative evaluation of a novel FLUorescENt C-mEt tracer in penile and tongue cancer - INFLUENCE-study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48118

Enrollment

Registered

2019-10-07

Start date

2019-12-17

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

penile carcinoma and tongue carcinoma

Interventions

All patients will receive an intravenous bolus injection of EMI-137 prior to surgery.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age >= 18 years at time of study entry. • >= T1 penile or tongue squamous cell cancer • Scheduled for surgical primary tumour resection

Exclusion criteria

Exclusion criteria: • 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
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 excised tissue.	—

Secondary

Measure	Time frame
- Detection and visualization of lymph node metastases in penile and tongue tumour patients - Identification of dysplasia or carcinoma in situ in penile and tongue tumours. - Toxicity by CTCAE-NCI V4	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)