Fluorescence imaging to improve surgery for oral cancer
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
This study is testing a new imaging agent to see if it can help doctors remove oral cancer more accurately during surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT04191460 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of cRGD-ZW800-1 for fluorescence-guided surgery in patients with oral cancer. It consists of two work packages: the first determines the optimal dose of the imaging agent to assess tumor margins, while the second evaluates whether this imaging technique can enhance surgical resection outcomes. A total of 21 patients will be included to assess the effectiveness of fluorescence imaging in improving surgical precision and outcomes. The study aims to provide insights into the sensitivity and specificity of this imaging method.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven squamous cell carcinoma of the oral cavity who are eligible for surgical resection.
Not a fit: Patients who have had previous surgery, chemotherapy, or radiotherapy to the oral cavity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical resections and better outcomes for patients with oral cancer.
How similar studies have performed: Other studies have shown promise in using fluorescence imaging for cancer surgery, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor; 2. ≥ 18 years of age; 3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations; 4. 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. Exclusion Criteria: 1. Previous surgery, chemotherapy or radiotherapy to the oral cavity; 2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent. 3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential; 4. Patients with renal insufficiency (eGFR\<60); 5. Patients with a previous kidney transplantation in the medical history; 6. 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; 7. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Stijn Keereweer, MD PhD
- Email: s.keereweer@erasmusmc.nl
- Phone: 010 704 13 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.