NCT07066774

Biopsy Needle Size in Soft Tissue Sarcoma

Diagnostic Accuracy of Different Tru-Cut Needle Sizes in Soft Tissue Sarcomas: A Prospective Blinded Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Soft tissue sarcomas (STS) require accurate biopsy for diagnosis, grading, and management decisions. Although tru-cut biopsy is widely used, the optimal needle gauge remains uncertain. This study aimed to compare diagnostic accuracy and biopsy concordance rates of 14 G, 16 G, and 18 G tru-cut biopsy needles for extremity STS. 1. Is there any difference between the diagnostic accuracy measurements of 14G, 16G and 18G tru-cut biopsy needles for diagnosis of soft tissue sarcomas in extremities? 2. Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the "matching score"s of biopsies? 3. Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the biopsy result concordance and/or diagnostic accuracy measurements? 4. Does needle gauge effect successful tumoral tissue sampling or prediction of histological grade of soft tissue sarcomas?

Detailed description

In 2018, the National Comprehensive Cancer Network (NCCN) endorsed core-needle (tru-cut) biopsy as the preferred diagnostic modality for STSs \[14\]. They recommend obtaining at least three tissue core blocks through a single stab incision on the skin, with a 14-gauge needle, directing the needle along different trajectories. In clinical practice, both 14 G and 16 G cores are commonly used Although multiple tru-cut needle gauges are used in practice, to our knowledge, an ideal and safe biopsy needle that does not sacrife diagnostic performance has not been defined. This is a randomized prospective disagnostic accuracy study. Therefore we prospectively compared numerous variables (tumor size, tumor depth, subtype, histological grade etc.) with biopsy result concordance and diagnostic accuracy of 14 G, 16 G, and 18 G tru-cut needles in samples obtained from the same tumor for each patient with suspected extremity STS, to determine whether an optimal needle gauge exists.

Conditions

• Soft Tissue Sarcoma of the Limb

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Tru-cut Biopsy with 14 G Needle	Each participant underwent Percutaneous Tru-cut Biopsy with 14G tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor
DIAGNOSTIC_TEST	Tru-cut Biopsy with 16G tru-cut needle	Each participant underwent Percutaneous Tru-cut Biopsy with 16 tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor
DIAGNOSTIC_TEST	Tru-cut Biopsy with 18G tru-cut needle	Each participant underwent Percutaneous Tru-cut Biopsy with 18G tru-cut needle in a single session procedure. There are no studies to our knowledge to compare samples from the same tumor

Timeline

• Start date: 2025-02-03
• Primary completion: 2025-06-01
• Completion: 2025-06-18
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Turkey (Türkiye)