NCT05554133 Precision Optical Guidance for Oral Biopsy
| NCT ID | NCT05554133 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Oral Lesions |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-06-15 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-06-15 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.
Eligibility Criteria
Inclusion Criteria: 1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible. 2. Ability to understand and willingness to sign a written Informed Consent Document (ICD). Exclusion Criteria: 1. Known allergy to proflavine or acriflavine. 2. Age less than 18 years. 3. Pregnant or nursing females. 4. Adults unable to consent 5. Prisoners and other vulnerable populations
Contact & Investigator
Ann Gillenwater, MD
PRINCIPAL INVESTIGATOR
MD Anderson Caner Center
Frequently Asked Questions
Who can join the NCT05554133 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oral Lesions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05554133 currently recruiting?
Yes, NCT05554133 is actively recruiting participants. Contact the research team at agillenw@mdanderson.org for enrollment information.
Where is the NCT05554133 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05554133 clinical trial?
NCT05554133 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Ann Gillenwater, MD at MD Anderson Caner Center. The trial plans to enroll 90 participants.