MDACC Study Summary 2006-0673

Study Summary
No. 2006-0673:.......Head And Neck......Ann M. Gillenwater......Head/Neck Surgery

Study Summary Title



Study Summary Number:	2006-0673

Study Title:	Oral Tumor Margin Detection Using Optical Spectroscopy

Physician

New Patient Referral



Name:	Ann M. Gillenwater	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Head/Neck Surgery	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8841 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	This study requires a one-time intervention with the subject.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to evaluate an imaging technology that may help clinicians see how far an area of pre-cancerous or cancerous tissue extends in the mouth.

Study Objectives / Outcomes

The overall objective of this exploratory study is to evaluate the ability of optical spectroscopy to assist in margin detection for tumor resection in the oral cavity. This may provide a non-invasive method to help surgeons delineate the precise areas involved in cancerous or pre-cancerous changes at the time of surgery, which should directly impact the quality of patient care. The specific objectives of this study are to:

· Evaluate the peripheral extent of oral neoplastic lesions using a non-invasive multispectral imaging device and standard white light imaging.

· Evaluate peripheral mucosal tumor margins using a non-invasive spectroscopic point probe device.

· Compare the margins of dysplasia and carcinoma identified by multispectral imaging and spectroscopic data to those defined clinically and by histopathology.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	12/20/2006

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with a lesion or history of a lesion of the oral mucosa.

2) Subjects with the ability and willingness to sign an informed consent and authorization.

Exclusion Criteria:

1) Persons who are medically unfit to undergo surgery.

2) Persons under the age of 18.

Links

Registration Number: NCT00439205
Study Information on Clinical Trials Registry (clinicaltrials.gov)