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Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders

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ClinicalTrials.gov Identifier: NCT02790853
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

May 26, 2016
June 6, 2016
November 21, 2018
May 25, 2016
May 31, 2026   (Final data collection date for primary outcome measure)
Detection of high grade dysplasia and carcinoma [ Time Frame: 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).
Multimodal Imaging for Detection of High Grade Dysplasia and Carcinoma [ Time Frame: 2 years ]
Clinical examination and multimodal imaging used to correlate with pathologically confirmed high grade dysplasia and early carcinoma.
Complete list of historical versions of study NCT02790853 on ClinicalTrials.gov Archive Site
  • Diagnostic assessment [ Time Frame: Up to 2 years ]
    Will determine qualitative and quantitative diagnostic assessment of patients who agree to undergo imaging and have images of sufficient quality.
  • Biomarker analysis [ Time Frame: 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.
  • Cytologic results [ Time Frame: Up to 2 years ]
    Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.
  • Lesion Progression [ Time Frame: 2 years ]
    Progression defined as lesions which develop histologic evidence of severe dysplasia, CIS, or cancer.
  • Lesion Progression [ Time Frame: 2 years ]
    Progression defined as lesions which progress by two or more grades on the continuum from normal to hyperplasia to mild dysplasia to moderate dysplasia to severe dysplasia to CIS to cancer.
Not Provided
Not Provided
 
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
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.

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.

Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Dysplasia
  • Lip and Oral Cavity Carcinoma
  • Oral Disorder
  • Premalignant Lesion
  • Procedure: Biopsy
    Undergo brush biopsy and incisional biopsy
    Other Name: Bx
  • Procedure: Fluorescence Imaging
    Undergo PS2.1/PS3 imaging
  • Procedure: High-Resolution Microendoscopy
    Undergo HRME imaging
    Other Name: HRME
  • Drug: Proflavine Hemisulfate
    Applied on mucosa
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.
Interventions:
  • Procedure: Biopsy
  • Procedure: Fluorescence Imaging
  • Procedure: High-Resolution Microendoscopy
  • Drug: Proflavine Hemisulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Same as current
May 31, 2026
May 31, 2026   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Ann Gillenwater 713-792-8441 agillenw@mdanderson.org
United States
 
 
NCT02790853
2014-0831
NCI-2018-02554 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0831 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Ann Gillenwater M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP