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Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Realtime Fluorescence Imaging
EU CTIS ID: 2024-512824-13-01
What this study is testing
To improve adequate resection of oral cancer using fluorescent imaging technology: 1. To determine the recommended dose for the highest tumor-tobackground ratio (TBR) of at least >1.5 using cRGD-ZW800-1 in oral cancer; 2. To increase the rate of adequate (i.e. >5mm clear) tumor resection margins
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- Patients ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
You likely can't join if
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
- Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);
See the full eligibility criteria
- Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
- Patients ≥ 18 years of age;
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- Previous surgery, chemotherapy or radiotherapy to the oral cavity;
- History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
- Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
- Patients with renal insufficiency (eGFR<60);
- Patients with a previous kidney transplantation in the medical history;
- Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);
- 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;
- Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient's wellbeing or the study objectives.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.