Fluorescent Visualization in Early Oral Cancer

U

University of Calgary

Status

Completed

Conditions

Oral Squamous Cell Carcinoma or Severe Dysplasia

Treatments

Procedure: resection of oral cancer

Study type

Interventional

Funder types

Other

Identifiers

NCT02306967

UCENT004

Details and patient eligibility

About

Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

biopsy proven invasive oral cancer or severe dysplasia / Cis
invasive cancer must be T1 or T2
no prior history of oral cancer / treatment of oral cancer

Exclusion criteria

prior history of oral cancer
unable to provide informed consent
lesion not able to be completely visualized by FV

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

Standard Resection

Active Comparator group

Description:

Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer.

Treatment:

Procedure: resection of oral cancer

FV Guided Resection

Experimental group

Description:

The oral resection will be guided by fluorescent visualization (FV).

Treatment:

Procedure: resection of oral cancer