To study CT scan accuracy in measuring tumor in case of buccal cancers

Phase 2

Recruiting

Conditions: patients with histologically proven squamous cell carcinoma of the oral cavity with doubtful invasion of the skin as assessed clinically by the principal investigator will be enrolled in the study.

Registration Number: CTRI/2017/01/007701

Lead Sponsor: NA

Brief Summary: 50 patientswith histologically proven squamous cell carcinoma of the oral cavity withdoubtful invasion of the skin as assessed clinically by the principalinvestigator will be enrolled in the study.

The CT scan would be performed on 16row MDCT (Multi Detector Computed Tomography) scanner with patient in supineposition and after administration on intravenous iodine containing (300mg ofiodine per ml) contrast. The scans would be performed from the root of the neckto the skull base with slice thickness of 2.5 mm, from the volume so acquired0.625 thick slices would be generated for viewing in soft issue and bonealgorithm and for multiplanar reformatting in coronal and sagittal planes.

From the images so generated, tumordimensions including depth would be ascertained. Distance from the outermost edge of the tumor to the skin will becalculated by a senior radiologist. We also make a note of presence orabsence and extent of fat stranding in the subcutaneous tissue, whether it (fatstranding) is reaching up to the skin and if there is skin thickening orinfiltration by the lesion.

All these patientswill be subjected to surgery and intraoperative decision to excise the skinwill be taken by operating surgeon irrespective of the calculated distancebetween the tumor and the skin on CT scan. All resected specimens will beevaluated in accordance with a standardized protocol. This will entailrecording the greatest antero-posterior (longitudinal) and medio-lateral(transverse) dimensions of the tumor in millimeters. The tumor will be slicedat 4-5 mm thickness, perpendicular to the tumor longitudinal axis. Maximumtumor thickness and the closest distance of the tumor from the skin (or thelateral soft tissue in cases where skin has not been removed) will be recorded.The tumor thickness, depth of invasion and distance from the overlying skinwill be confirmed on microscopy. Presence of subdermal lymphatics andmicroscopic skin thickness will also be recorded.

**Comparisonbetween CT & Histopathological Report (HPR) findings**

The CTscan findings will be compared with

histopathologicalfindings using SPSS version 18, Chicago IL USA. Correlation method will be usedto compare different variables. The depth of invasion or the maximum tumorthickness on CT scan will be compared with the depth of invasion / tumorthickness reported by the pathologist. Similarly comparison would be made oftumor dimensions in anteroâ€“posterior and transverse plane between CT scan andHPR findings. The comparison of values obtained by calculating the distancebetween the tumor and the skin on CT scan and that of those reported bypathologist would be made using correlation method. For each patient absence orpresence of fat stranding would be compared with absence or presence ofsubdermal lymphatic invasion by the tumor cells reported on histopathology.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

â€¢Histologically proven squamous cell carcinoma involving gingivobuccal complex â€¢Previously untreated gingivobuccal complex squamous cell carcinoma with doubtful invasion into the skin.
â€¢Study specific signed informed consent.

Exclusion Criteria

â€¢Frank ulceration/ fungation of the skin by the tumor â€¢Non squamous pathology â€¢Prior surgery, chemotherapy or radiotherapy to head neck region.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the computed tomography (CT) scan accuracy in determining the depth of invasion for the tumor involving gingivobuccal complex	at time of CT scan procedure done

Secondary Outcome Measures

Name	Time	Method
To decide the thickness of the tumor and to calculate the distance of tumor from the skin	Before surgery

Trial Locations

Locations (1): Tata Memorial Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Devendra Chaukar
Principal investigator
02224177000
dchaukar@gmail.com