Spectroscopy Versus Standard Care in Cervical Cancer Patients

Summary

Primary objectives

1. To conduct a randomized clinical trial of the emerging technology fluorescence and reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively.

The number of clinically read referral Paps, clinically read UT MD Anderson Cancer Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image, that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL), Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality is present.
2. To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone.

1. To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer.
2. To study the number of LEEP specimens that show HGSIL or cancer.

Conditions

• Cervical Cancer

Interventions

PROCEDURE

Fluorescence Spectroscopy

Pictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue.

PROCEDURE

Colposcopy

A standard colposcopy will be performed.

PROCEDURE

LEEP Procedure

A small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Helen E. Rhodes, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2008-08-31

Completion

2008-08-31

Countries

• United States
• Canada

Study Locations