DysplasiaEarly Phase 1NCT02790853
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
A Early Phase 1 study testing Biopsy, Fluorescence Imaging and High-Resolution Microendoscopy in people with Dysplasia and Lip and Oral Cavity Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysplasia, Lip and Oral Cavity Carcinoma, Oral Disorder
- What is being tested?
- Biopsy, Fluorescence Imaging and High-Resolution Microendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2016to 31 May 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are willing to participate.
- Adult subjects with: a. clinically evident oral premalignant lesion (OPL) or suspicious oral mucosal lesion. or b. pathologic diagnosis of dysplasia or c. history of resected oral cancer or d. oral potentially malignant disorder (OPMD) or e. history of tobacco and/or alcohol exposure.
- Ability to understand and willingness to sign a written informed consent document (ICD).
Who cannot join
- Known allergy to proflavine or acriflavine.
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).
SECONDARY OBJECTIVES:
- To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.
II. To compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.
III. To compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.
OUTLINE:
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.
After completion of study treatment, patients are followed up at 30 days.
- Being tested
- Biopsy, Fluorescence Imaging, High-Resolution Microendoscopy, Proflavine Hemisulfate
- Medical subject headings
- Mouth Neoplasms, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo brush biopsy and incisional biopsy
Fluorescence ImagingProcedure or surgery
Undergo PS2.1/PS3 imaging
High-Resolution MicroendoscopyProcedure or surgery
Also called HRME
Undergo HRME imaging
Proflavine HemisulfateDrug
Applied on mucosa
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (multimodal imaging, biopsy) | Experimental | 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. Receives: Procedure: Biopsy; Procedure: Fluorescence Imaging; Procedure: High-Resolution Microendoscopy; Drug: Proflavine Hemisulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of high grade dysplasia and carcinoma
Will compare standard white light examination to multimodal imaging for detection of high grade dysplasia and carcinoma during follow-up examinations of patients with oral potentially malignant disorders (OPMD).
Measured: Up to 2 years
Secondary outcomes (3)
Diagnostic assessment
Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.
Measured: Up to 2 years
Biomarker analysis
Will compare expression of molecular biomarkers to results from white light examination, multimodal imaging and pathologic assessment in a subset of patients who have invasive biopsies or resection.
Measured: Up to 2 years
Cytologic results
Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start25 May 2016
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysplasiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ann Gillenwater, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790853
- Sponsor's protocol ID
- 2014-0831
- Other IDs
- NCI-2018-02554, 2014-0831, P30CA016672
- Status last verified
- Oct 2026
- First submitted
- 26 May 2016
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes