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Multispectral + High-Resolution Microendoscopy for Oral Cancer

Q: What is the current involvement in this clinical trial?

Affirmative. Per the information hosted on clinicaltrials.gov, recruitment for this medical trial is ongoing as of October 31st 2022; it was first activated at the end of 2010 and requires a total of 275 participants from one location.

Q: Is this study currently seeking participants?

Affirmative. The clinical trial, initially posted on December 30th 2010, is recruiting for 275 patients from a single site and the details can be found on clinicaltrials.gov which was last updated October 31st 2022.

Q: Has High-Resolution Microendoscopy been explored in past medical experiments?

Currently, three trials are underway to evaluate the efficacy of High-Resolution Microendoscopy. None of these investigations have reached Phase 3 status yet. While they <a href="https://www.withpower.com/clinical-trials/all">all</a> originate from Houston, <a href="https://www.withpower.com/clinical-trials/texas">Texas</a>, there are other testing sites in operation as well.

Phase < 1

Recruiting

Led By Ann Gillenwater

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial looks at using different colors of light to get a better look at mouth lesions during surgery, which may help doctors better identify which ones are pre-cancerous or cancerous.

Who is the study for?

This trial is for adults with oral lesions who are already scheduled for surgery to remove or biopsy these areas. Participants must understand and be willing to sign a consent form. It's open to those who've had previous treatments.Check my eligibility

What is being tested?

The study tests imaging techniques like wide-field and high-resolution in vivo imaging, using multispectral lights and proflavine dye, to better visualize mouth lesions during surgery and assess their cancer risk.See study design

What are the potential side effects?

Potential side effects may include mild discomfort from the imaging process or reactions to the proflavine dye such as local irritation. However, detailed side effect profiles will depend on individual patient responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Classification of tissue

Evaluation of oral mucosa to be used for non-invasive detection and diagnosis with the use of optical imaging after administration of the topical contrast agent proflavine.

Secondary outcome measures

Percentage of subjects and lesions that can be successfully imaged with wide-field and high-resolution optical microscopes after topical application of contrast dye

Qualitative features within images that differ between pathologically normal, dysplastic, cancerous and inflammatory lesions

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (widefield multispectral imaging and HRME)Experimental Treatment3 Interventions

Patients undergo evaluation of oral cavity using a widefield multispectral imaging device and a high-resolution optical system (HRME) at baseline, after induction of general anesthesia, and prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proflavine

2015

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,579 Total Patients Enrolled

8 Trials studying Oral Cancers

1,753 Patients Enrolled for Oral Cancers

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,071 Total Patients Enrolled

5 Trials studying Oral Cancers

769 Patients Enrolled for Oral Cancers

Ann GillenwaterPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

Multispectral Imaging Clinical Trial Eligibility Overview. Trial Name: NCT01269190 — Phase < 1

Oral Cancers Research Study Groups: Diagnostic (widefield multispectral imaging and HRME)

Oral Cancers Clinical Trial 2023: Multispectral Imaging Highlights & Side Effects. Trial Name: NCT01269190 — Phase < 1

Multispectral Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT01269190 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current involvement in this clinical trial?

"Affirmative. Per the information hosted on clinicaltrials.gov, recruitment for this medical trial is ongoing as of October 31st 2022; it was first activated at the end of 2010 and requires a total of 275 participants from one location."

Answered by AI

Is this study currently seeking participants?

"Affirmative. The clinical trial, initially posted on December 30th 2010, is recruiting for 275 patients from a single site and the details can be found on clinicaltrials.gov which was last updated October 31st 2022."

Answered by AI

Has High-Resolution Microendoscopy been explored in past medical experiments?

"Currently, three trials are underway to evaluate the efficacy of High-Resolution Microendoscopy. None of these investigations have reached Phase 3 status yet. While they all originate from Houston, Texas, there are other testing sites in operation as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery

2010. "Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01269190.

All > Uti > Texas