The Study of Folate Receptor-Mediated Staining Solution (FRD™) In Cervical Lesion Detection

PHASE3UnknownINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

December 7, 2018

Study Completion Date

December 7, 2018

Conditions
Cervical Intraepithelial Neoplasia Grade 2/3
Interventions
COMBINATION_PRODUCT

FRD

The Folate Receptor-Mediated Staining Solution is a dye solution that stains for medical purposes used in staining cells and tissues for detecting neoplastic diseases. After inserting a speculum into your vagina, the FRD™ staining solution will be applied to the cervix using an applicator. After removal of the applicator, the doctor will inspect the applicator for color changes and note any changes. The physician will then remove any excess stain from the cervix using distilled water.

OTHER

Cytology

Cytology testing done by collecting samples of cells, and smearing those samples across a glass microscope slide in order to detect abnormal cells that may develop into cervical cancer.

OTHER

HPV testing

HPV tests will detect HPV infections, which can lead to cervical cells to become cancer cells.

PROCEDURE

Colposcopy

During the colposcopic examination, the physician will insert a speculum into the vagina and then apply a vinegar solution to the cervix. The vinegar solution causes any potential abnormal cells to turn white. These white regions are best seen using the colposcope, which magnifiesthe skin.

PROCEDURE

ECC

If the examination is not satisfactory and the doctor is not able to see the entire cervix, he may perform an endocervical curettage, or ECC. This sample is collected by placing a long, thin instrument into the cervical canal and a sample is scraped from that area. The sample will be sent to the laboratory for a pathologist to review.

PROCEDURE

Biospy

"According to the colposcopy assessment, if the doctor sees a white area, or an area of abnormal cells, a tiny sample of tissue, called a biopsy will be taken from the cervix. About half of women do not feel the biopsy being taken.~Others may feel a quick pinch. After the biopsy, the wound will be treated to stop bleeding.The biopsy will be sent to the laboratory for a pathologist to review."

Trial Locations (1)

30912

RECRUITING

Augusta University, Augusta

Sponsors
All Listed Sponsors
lead

GY Highland Biotech LLC

INDUSTRY