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NCT00250055 Clinical Trial

Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue

Cancer Clinical Trial

Official title:
Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00250055
Other study ID # 1104C
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2004
Est. completion date January 2010

Study information
Verified date March 2024
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance. Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells. Develop and implement quantitative and sensitive methods for measuring morphological properties. Clinical measurements.

Description:

Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.

Recruitment information / eligibility
Status Terminated
Enrollment 100
Est. completion date January 2010
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with abnormal Pap smears who are referred for colposcopy. Exclusion criteria include: - Anyone of the male sex since this study focuses on cervical cell abnormalities - Any woman who has had a hysterectomy, LEEP, or chemotherapy.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Colposcopy, Spectroscopy, and Biopsy
During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions. 6 years
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