NCT04191460CompletedPhase 2
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 5 Dec 2019
- Start date
- 12 Jul 2022
- Primary completion date
- 16 May 2025
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Head and neck cancer
- NCT number
- NCT04191460
- EudraCT number
- 2019-003416-30
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 12 Jul 2022 to the primary completion date, 16 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- Patients with a previous kidney transplantation in the medical history;
- Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
Other illness
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Lab values
- Patients with renal insufficiency (eGFR\<60);
Other
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
Who the study is looking for
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.