Ongoing Clinical Trials for Lip and Oral Cavity Cancer
There are currently 2 clinical trials investigating new approaches to improve the diagnosis and treatment of lip and oral cavity cancer. These studies are testing advanced imaging techniques that help surgeons identify cancer more accurately during procedures, with both trials taking place in the Netherlands.
Clinical trial locations
- Netherlands
Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer
This trial is investigating a new imaging method to help identify sentinel lymph nodes in patients with certain types of cancer, including those with cancer of the mouth. Sentinel lymph nodes are the first nodes where cancer is most likely to spread from the original tumor site, making them important to identify and examine.
Main inclusion criteria: Participants must be older than 18 years and have been diagnosed with a primary oral cavity cancer classified as T1-2N0, meaning a small cancer in the mouth that has not yet spread to the lymph nodes. Patients must be scheduled for a sentinel node biopsy as part of their regular medical care, with no clinical evidence of cancer in the lymph nodes.
Main exclusion criteria: Patients who are not scheduled for a sentinel node biopsy cannot participate in this study.
Focus and goal: The study aims to validate a new hybrid tracer method that combines two substances: Indocyanine Green and Technetium (99mTc) Nanocolloid. These substances, known together as ICG-99mTc-nanoscan, help doctors visualize sentinel nodes using both fluorescence and radioactivity during imaging. Participants receive an injection of these tracers, and imaging techniques including lymphoscintigraphy and SPECT/CT are used to locate the sentinel nodes before surgery. The study compares this hybrid method with the standard approach to determine if it can identify the same number of sentinel nodes with equal accuracy.
Investigational drugs: The trial uses ICG-99mTc-nanoscan, a hybrid tracer that combines a fluorescent dye with a radioactive component. This combination allows doctors to use both fluorescence and radioactive signals to improve the accuracy of detecting sentinel nodes during procedures. The standard comparator is 99mTc-nanoscan, which uses only the radioactive component.
Study on Improving Oral Cancer Surgery Using cRGD-ZW800-1 Fluorescent Imaging for Patients with Oral Cancer
This trial focuses on improving surgical outcomes for patients with cancer of the mouth by using advanced fluorescence imaging technology. The goal is to help surgeons see cancerous tissue more clearly during operations, ensuring that all cancer is removed while preserving as much healthy tissue as possible.
Main inclusion criteria: Participants must be 18 years or older and have a confirmed diagnosis of squamous cell carcinoma of the oral cavity, verified through biopsy. They must be suitable candidates for surgery to remove the primary tumor and must provide written informed consent before joining the study.
Main exclusion criteria: Patients who are younger than 18 or older than 65 years cannot participate. Those who are part of vulnerable populations, such as individuals unable to provide consent or in dependent relationships, are also excluded.
Focus and goal: The study aims to find the best dose of cRGD-ZW800-1 that will make cancerous tissue stand out from healthy tissue during surgery. The medication is given through an intravenous infusion before the operation. During surgery, surgeons use special fluorescence imaging equipment that causes the cancer to glow under specific lighting, making it easier to remove the tumor completely with a safe margin of healthy tissue around it. The study will monitor how well this technique works in achieving clear surgical margins and identifying cancer that may have spread to nearby lymph nodes.
Investigational drug: The trial uses cRGD-ZW800-1, a fluorescent imaging agent that binds to specific proteins on cancer cells. When exposed to certain lighting conditions during surgery, it emits fluorescence that helps surgeons visualize the exact location and boundaries of the tumor. This allows for more precise removal of cancerous tissue while sparing healthy tissue.
Summary
Both ongoing clinical trials for lip and oral cavity cancer are taking place in the Netherlands and focus on improving surgical precision through advanced imaging techniques. The first trial validates a hybrid tracer method for sentinel node identification, which is crucial for determining if cancer has spread. The second trial tests a fluorescent imaging agent that helps surgeons visualize tumor boundaries during removal procedures.
These studies represent important advances in surgical guidance for patients with cancer of the mouth. Both approaches aim to improve treatment outcomes by ensuring more accurate cancer detection and complete removal during surgery. The fluorescence imaging technologies being tested could potentially reduce the risk of leaving cancer cells behind and improve long-term outcomes for patients.