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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

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
Dysplasia Lip and Oral Cavity Carcinoma Oral Disorder Premalignant Lesion Procedure: Biopsy Procedure: Fluorescence Imaging Procedure: High-Resolution Microendoscopy Drug: Proflavine Hemisulfate Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2026


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 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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Cytologic results [ Time Frame: Up to 2 years ]
    Will compare cytologic results from brush biopsy specimens to white light examination and multimodal imaging results.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790853


Contacts
Contact: Ann Gillenwater 713-792-8441 agillenw@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ann M. Gillenwater    713-792-8841      
Principal Investigator: Ann M. Gillenwater         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann Gillenwater M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02790853     History of Changes
Other Study ID Numbers: 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 )
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
Mouth Diseases
Lip Neoplasms
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Disease
Precancerous Conditions
Pathologic Processes
Stomatognathic Diseases
Lip Diseases
Proflavine
Anti-Infective Agents, Local
Anti-Infective Agents