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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

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 6, 2016
Last Update Posted Date November 21, 2018
Actual Study Start Date  ICMJE May 25, 2016
Estimated Primary Completion Date May 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
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.
Change History Complete list of historical versions of study NCT02790853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2016)
  • 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.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
Official Title  ICMJE Multimodal Imaging for Surveillance of Patients With Oral Potentially Malignant Disorders
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Dysplasia
  • Lip and Oral Cavity Carcinoma
  • Oral Disorder
  • Premalignant Lesion
Intervention  ICMJE
  • 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
Study Arms 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2016)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date May 31, 2026
Estimated Primary Completion Date May 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Ann Gillenwater 713-792-8441 agillenw@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02790853
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Ann Gillenwater M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date November 2018

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