Imaging techniques to visualize lesions in patients with oral neoplasia during surgery
Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
This study is testing new imaging techniques to help doctors see and identify abnormal tissue in patients with oral tumors during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT01269190 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of wide-field and high-resolution in vivo imaging techniques to visualize lesions in patients with oral neoplasia who are undergoing surgical procedures. The study aims to assess the feasibility of these imaging methods, which involve the use of advanced optical devices and a contrast agent, to differentiate between normal and abnormal tissue. Additionally, it seeks to develop algorithms for classifying tissue based on quantitative parameters extracted from the images. Patients will be monitored for three months following the imaging and surgical intervention.
Who should consider this trial
Good fit: Ideal candidates include adult patients with oral lesions who are scheduled for surgical resection in the head and neck area.
Not a fit: Patients who are pregnant, nursing, or have known allergies to the contrast agent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing oral lesions, potentially leading to better treatment outcomes for patients.
How similar studies have performed: Other studies utilizing advanced imaging techniques have shown promise in improving diagnostic accuracy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects with oral lesions undergoing surgical resection (i.e., only patients who are scheduled to undergo a surgery of the head \& neck area to remove or biopsy oral lesions will be eligible to participate in the study); patients with previous treatment are eligible * Ability to understand and the willingness to sign a written informed consent document (ICD) Exclusion Criteria: * Known allergy to proflavine or acriflavine * Pregnant or nursing females * The participant will be excluded from participation in another clinical research trial (i.e., a trial in which an agent is actively administered to the study subject), while being imaged (on active treatment) on this protocol
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ann Gillenwater — M.D. Anderson Cancer Center
- Study coordinator: Ann Gillenwater
- Email: agillenw@mdanderson.org
- Phone: 713-792-8841
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.