Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
Sponsor: M.D. Anderson Cancer Center
A observational or N/A phase clinical study on Dysplasia and Lip and Oral Cavity Carcinoma, this trial is ongoing. The trial is conducted by M.D. Anderson Cancer Center and has accumulated 19 data snapshots since 2016. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. 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:
I. 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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Status Flow
Change History
19 versions recorded-
Apr 16, 2026 — Present [daily]
Active Not Recruiting
Phase: EARLY_PHASE1 → None
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Nov 2025 — Apr 2026 [monthly]
Active Not Recruiting EARLY_PHASE1
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Jun 2025 — Nov 2025 [monthly]
Active Not Recruiting EARLY_PHASE1
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Dec 2024 — Jun 2025 [monthly]
Active Not Recruiting EARLY_PHASE1
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Sep 2024 — Dec 2024 [monthly]
Active Not Recruiting EARLY_PHASE1
▶ Show 14 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting EARLY_PHASE1
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Mar 2024 — Jul 2024 [monthly]
Active Not Recruiting EARLY_PHASE1
Status: Recruiting → Active Not Recruiting
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Dec 2023 — Mar 2024 [monthly]
Recruiting EARLY_PHASE1
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Sep 2023 — Dec 2023 [monthly]
Recruiting EARLY_PHASE1
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Mar 2023 — Sep 2023 [monthly]
Recruiting EARLY_PHASE1
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Nov 2022 — Mar 2023 [monthly]
Recruiting EARLY_PHASE1
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Jan 2021 — Nov 2022 [monthly]
Recruiting EARLY_PHASE1
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Jan 2020 — Jan 2021 [monthly]
Recruiting EARLY_PHASE1
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Dec 2018 — Jan 2020 [monthly]
Recruiting EARLY_PHASE1
Phase: NA → EARLY_PHASE1
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Jun 2018 — Dec 2018 [monthly]
Recruiting NA
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Dec 2017 — Jun 2018 [monthly]
Recruiting NA
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Jun 2017 — Dec 2017 [monthly]
Recruiting NA
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Feb 2017 — Jun 2017 [monthly]
Recruiting NA
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Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
May 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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.
Contact Information
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .