Biopsy Needle Size in Soft Tissue Sarcoma

NCT ID: NCT07066774

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-03
• Study Completion Date: 2025-06-18

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

14G Needle

Each patient undergoes a tru-cut biopsy with a 14 G needle, obtaining 5 tissue cores (tumor center, superior, inferior, medial, lateral).

Group Type: EXPERIMENTAL

Tru-cut Biopsy with 14 G Needle

Intervention Type: DIAGNOSTIC_TEST

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

16G Needle

Each participant underwent Percutaneous Tru-cut Biopsy with 16G tru-cut needles in a single session procedure and within-subject repeated measuring data is obtained

Group Type: EXPERIMENTAL

Tru-cut Biopsy with 16G tru-cut needle

Intervention Type: DIAGNOSTIC_TEST

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

18G Needle

Each participant underwent Percutaneous Tru-cut Biopsy with 16G tru-cut needles in a single session procedure and within-subject repeated measuring data is obtained

Group Type: EXPERIMENTAL

Tru-cut Biopsy with 18G tru-cut needle

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on physical examination suggesting soft tissue sarcoma.

Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on radiological imaging suggesting soft tissue sarcoma.

Patients with soft tissue masses in extremities which require pathological examination

Exclusion Criteria

• Patients with a prior diagnosis of the existing mass, coagulation disorders, active infection at the tumor site, a history of previous surgery or radiotherapy to the tumor region, medical conditions contraindicating tru-cut biopsy, or those who did not consent to participate after detailed explanation of the study, were excluded.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geotek Medical Products Industry and Trade Co., Ltd., Ankara, Türkiye

UNKNOWN

Sponsor Role: collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara Bilkent City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Birgin E, Yang C, Hetjens S, Reissfelder C, Hohenberger P, Rahbari NN. Core needle biopsy versus incisional biopsy for differentiation of soft-tissue sarcomas: A systematic review and meta-analysis. Cancer. 2020 Jan 1;126(9):1917-1928. doi: 10.1002/cncr.32735. Epub 2020 Feb 5.

Reference Type: BACKGROUND

PMID: 32022262 (View on PubMed)

Other Identifiers

E2-25-10025

Identifier Type: -

Identifier Source: org_study_id