Trials / Completed
CompletedNCT04574427
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 5 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
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.
Conditions
Timeline
- Start date
- 2019-11-13
- Primary completion
- 2020-11-13
- Completion
- 2020-11-14
- First posted
- 2020-10-05
- Last updated
- 2022-10-19
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04574427. Inclusion in this directory is not an endorsement.