Spots Global Cancer Trial Database for INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

Official Title: INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

Study ID: NCT04574427

Conditions

Head and Neck Cancer

Penile Cancer

Interventions

Study Description

Brief 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.