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Active Not Recruiting INTERVENTIONAL NCT02790853

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

Updated 19 times since 2017 Last updated: Apr 10, 2026 Started: May 25, 2016 Primary completion: May 31, 2026 Completion: May 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Dec 2017 · 6 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Jan 2020 · 13 months · monthly snapshot~Jan 2020 – ~Jan 2021 · 12 months · monthly snapshot~Jan 2021 – ~Nov 2022 · 22 months · monthly snapshot~Nov 2022 – ~Mar 2023 · 4 months · monthly snapshot~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Mar 2024 · 3 months · monthly snapshot~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jun 2025 · 6 months · monthly snapshot~Jun 2025 – ~Nov 2025 · 5 months · monthly snapshot~Nov 2025 – ~Apr 2026 · 5 months · monthly snapshotApr 16, 2026 – present · 3 months · daily API

Change History

19 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Active Not Recruiting

    Phase: EARLY_PHASE1None

  2. Nov 2025 — Apr 2026 [monthly]

    Active Not Recruiting EARLY_PHASE1

  3. Jun 2025 — Nov 2025 [monthly]

    Active Not Recruiting EARLY_PHASE1

  4. Dec 2024 — Jun 2025 [monthly]

    Active Not Recruiting EARLY_PHASE1

  5. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

Show 14 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

  2. Mar 2024 — Jul 2024 [monthly]

    Active Not Recruiting EARLY_PHASE1

    Status: RecruitingActive Not Recruiting

  3. Dec 2023 — Mar 2024 [monthly]

    Recruiting EARLY_PHASE1

  4. Sep 2023 — Dec 2023 [monthly]

    Recruiting EARLY_PHASE1

  5. Mar 2023 — Sep 2023 [monthly]

    Recruiting EARLY_PHASE1

  6. Nov 2022 — Mar 2023 [monthly]

    Recruiting EARLY_PHASE1

  7. Jan 2021 — Nov 2022 [monthly]

    Recruiting EARLY_PHASE1

  8. Jan 2020 — Jan 2021 [monthly]

    Recruiting EARLY_PHASE1

  9. Dec 2018 — Jan 2020 [monthly]

    Recruiting EARLY_PHASE1

    Phase: NAEARLY_PHASE1

  10. Jun 2018 — Dec 2018 [monthly]

    Recruiting NA

  11. Dec 2017 — Jun 2018 [monthly]

    Recruiting NA

  12. Jun 2017 — Dec 2017 [monthly]

    Recruiting NA

  13. Feb 2017 — Jun 2017 [monthly]

    Recruiting NA

  14. 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

Sponsor contact:
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations