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Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02790853
Collaborator
National Cancer Institute (NCI) (NIH)
600
Enrollment
1
Location
1
Arm
120.2
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy
  • Procedure: Fluorescence Imaging
  • Procedure: High-Resolution Microendoscopy
  • Drug: Proflavine Hemisulfate
 Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

  1. To determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

  2. 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.

  3. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
Actual Study Start Date :
May 25, 2016
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (multimodal imaging, biopsy)

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.

Procedure: Biopsy
Undergo brush biopsy and incisional biopsy
Other Names:
  • Bx

    • Procedure: Fluorescence Imaging
    Undergo PS2.1/PS3 imaging

    Procedure: High-Resolution Microendoscopy
    Undergo HRME imaging
    Other Names:
  • HRME

    • Drug: Proflavine Hemisulfate
    Applied on mucosa

    Outcome Measures

    Primary Outcome Measures

    1. Detection of high grade dysplasia and carcinoma [Up to 2 years]

      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).

    Secondary Outcome Measures

    1. Diagnostic assessment [Up to 2 years]

      Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.

    2. Biomarker analysis [Up to 2 years]

      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.

    3. Cytologic results [Up to 2 years]

      Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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).

    Exclusion Criteria:

    • Known allergy to proflavine or acriflavine.

    • Pregnant females.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Ann Gillenwater, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02790853
    Other Study ID Numbers:
    • 2014-0831
    • NCI-2018-02554
    • 2014-0831
    • P30CA016672
    First Posted:
    Jun 6, 2016
    Last Update Posted:
    Dec 23, 2019
    Last Verified:
    Dec 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Proflavine

    Study Results

    No Results Posted as of Dec 23, 2019