Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later May 31, 2026 → May 31, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from May 31, 2026 to May 31, 2028
    • Eligibility criteria expanded, about 5 words
  2. 2 versions Re-verified since Oct 10, 2025, no change to tracked fieldsv16-v17
  3. Study Identification, Study Statusv15
  4. Study Identification, Study Statusv14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 600 to confirmed 63
    • Site details revised
    v12
  2. 5 versions Re-verified since Dec 19, 2019, no change to tracked fieldsv7-v11
  3. Phase: Not applicable to Early Phase 1v6 Show 11 more changesShow less
    • Primary endpoint revised
    • Primary completion date: May 2026 to May 31, 2026
    • Study completion date: May 2027 to May 31, 2026
    • Start date: May 2016 to May 25, 2016
    • Interventions: Brush Biopsy (Procedure), High-Resolution Optical System (HRME) (Device), PS2.1/PS3 Imaging (Device), Proflavine Hemisulfate (Other)… to Biopsy (Procedure), Fluorescence Imaging (Procedure), High-Resolution Microendoscopy (Procedure), Proflavine Hemisulfate (Drug)
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 2 to 3
    • Study description shortened, about 576 words
    • Study site revised
    • Collaborators: 3 to 1
    • Study title revised
  4. Study completion date: May 2026 to May 2027
    • Study description shortened, about 34 words
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Study completion date: May 2026
    • Study description revised
    v3
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02790853
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Dysplasia, Lip and Oral Cavity Carcinoma, Oral Disorder, Premalignant Lesion
Related terms Mouth Diseases, Mouth Neoplasms
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov