Multimodal Imaging for Precancerous Oral Conditions

Recruiting in Palo Alto (17 mi)

Ann M. Gillenwater | MD Anderson Cancer ...

Overseen byAnn M. Gillenwater

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This early phase I trial studies how well multimodal imaging works for surveillance in patients with oral potentially malignant disorders. New types of imaging devices may help doctors decide if a lesion in the mouth is pre-cancerous or cancerous.

Eligibility Criteria

This trial is for adults with oral lesions that may become cancerous, a history of resected oral cancer, or exposure to tobacco/alcohol. Participants must be willing and able to consent. Pregnant individuals or those allergic to proflavine/acriflavine cannot join.

Inclusion Criteria

I had surgery to remove oral cancer.

Ability to understand and willingness to sign a written informed consent document (ICD)

I have a condition that might lead to mouth cancer.

+4 more

Exclusion Criteria

Known allergy to proflavine or acriflavine

Pregnant females

Participant Groups

The study tests new imaging methods (fluorescence imaging, high-resolution microendoscopy) using proflavine hemisulfate on patients with potentially malignant mouth disorders to see if these can identify pre-cancerous or cancerous lesions effectively.

1Treatment groups

Experimental Treatment

Group I: Diagnostic (multimodal imaging, biopsy)Experimental Treatment4 Interventions

Participants undergo PS2.1/PS3 imaging and high-resolution microendoscope imaging with proflavine hemisulfate applied to the mucosa. Patients also undergo brush biopsy and incisional biopsy. Procedures are repeated every 3-4 months for 2 years.