Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488332
Status:
TERMINATED
Last Update Posted:
2012-07-20
First Post:
2007-06-19
Brief Title:
An Exploratory Study on Optical Assessment of Oral Mucositis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
An Exploratory Study on Optical Assessment of Oral Mucositis
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
1 To assess the tolerability of performing optical coherence tomography andor optical spectroscopy in patients with acute oral mucositis
2 To determine the feasibility of obtaining optical coherence tomography images andor fluorescence excitation emission matrices from normal and affected sites in patients with acute oral mucositis
3 To compare optical data obtained with optical coherence tomography andor spectroscopy with the clinical appearance and scoring of oral mucositis lesions
1 To assess the tolerability of performing optical coherence tomography andor optical spectroscopy in patients with acute oral mucositis
2 To determine the feasibility of obtaining optical coherence tomography images andor fluorescence excitation emission matrices from normal and affected sites in patients with acute oral mucositis
3 To compare optical data obtained with optical coherence tomography andor spectroscopy with the clinical appearance and scoring of oral mucositis lesions
Detailed Description:
Optical coherence tomography OCT works similarly to ultrasound but uses infrared light waves rather than sound waves to create high-resolution pictures This tool has been approved by the Food Drug Administration FDA is used routinely for standard diagnosis of eye conditions and is now being used to look inside your mouth for tissue changes
For the OCT procedure a small probe about the size of a pencil eraser will be gently placed against the lining of your mouth and light will be shone through the probe to create pictures of the tissue The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth If there are no abnormal-looking areas researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue since these are the areas most often affected by the chemotherapy and radiation therapies
In fluorescence spectroscopy FS a small beam of light shines through a small probe onto the lining of the mouth A small amount of light will be emitted from the tissue in the form of fluorescence similar to glow in the dark toys This light is not seen by the eye but it is detected by the probe and recorded by a computer
For the FS procedure a small probe about the size of a pencil eraser will be gently placed against the lining of your mouth and light will be shone through the probe The probe will then collect the fluorescence light signals and they will be recorded on a computer The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth If there are no abnormal-looking areas researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue since these are the areas most often affected by the chemotherapy and radiation therapies
If you agree to take part in this study your mouth will be examined before your treatment begins and then once a week after that Every week you will also be asked how much pain you are having on a scale of 1-10
Photographs will be taken of the inside of the mouth with a standard camera You will not be identified in these photographs
You will be asked to return once a week until you finish all radiation treatments to have all the exams repeated Most radiation treatments last about 6-8 weeks
This is an investigational study About 18 patients will take part in this study All will be enrolled at M D Anderson
For the OCT procedure a small probe about the size of a pencil eraser will be gently placed against the lining of your mouth and light will be shone through the probe to create pictures of the tissue The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth If there are no abnormal-looking areas researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue since these are the areas most often affected by the chemotherapy and radiation therapies
In fluorescence spectroscopy FS a small beam of light shines through a small probe onto the lining of the mouth A small amount of light will be emitted from the tissue in the form of fluorescence similar to glow in the dark toys This light is not seen by the eye but it is detected by the probe and recorded by a computer
For the FS procedure a small probe about the size of a pencil eraser will be gently placed against the lining of your mouth and light will be shone through the probe The probe will then collect the fluorescence light signals and they will be recorded on a computer The probe will be placed on 1-2 abnormal-looking areas and 1 normal-looking area inside the mouth If there are no abnormal-looking areas researchers will place the probe and make pictures of an area on the inside of the cheek and side of the tongue since these are the areas most often affected by the chemotherapy and radiation therapies
If you agree to take part in this study your mouth will be examined before your treatment begins and then once a week after that Every week you will also be asked how much pain you are having on a scale of 1-10
Photographs will be taken of the inside of the mouth with a standard camera You will not be identified in these photographs
You will be asked to return once a week until you finish all radiation treatments to have all the exams repeated Most radiation treatments last about 6-8 weeks
This is an investigational study About 18 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None