NCT04741958

Brief Summary

The aim of the study was to calculate sensitivity, and accuracy of ultrasound guided percutaneous core needle biopsy in different thoracic tumors (lung, pleural, chest wall and mediastinal).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 17, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

October 17, 2020

Last Update Submit

February 4, 2021

Conditions

Keywords

Ultrasound; .Chest; DiseasesCore needle biopsy

Outcome Measures

Primary Outcomes (1)

  • Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).

    diagnostic performance of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal) in 60 patients that had radiographic evidence of thoracic mass suspected of malignancy by measure sensitivity, accuracy, and Positive predictive values * True positive result: the tumor is confirmed by a definite histopathologic diagnosis made by Tru-Cut core biopsy * True negative result: case not diagnosed as a tumor by ultrasound Tru-Cut core biopsy \& this finding was confirmed by another modality for biopsy * False negative result was considered to have occurred if the tumor wasn't diagnosed by ultrasound guided biopsy, and the tumor was confirmed using other modalities (CT guided, Thoracoscopic, or surgical biopsy).

    8week

Study Arms (1)

ultra sound guided percutaneous core needle biopsy

EXPERIMENTAL

60 patients that had radiographic evidence of thoracic mass suspected of malignancy .Twenty masses were in the lung, seventeen lesions were in the pleura, ten masses were in the mediastinum, eleven enlarged palpable lymph nodes, and two masses were in chest wall. The sensitivity, PPV and accuracy for detection of chest tumors in chest wall, mediastinum, lung, and pleura were (100 %) for all, and in LN (88.9, 100 and 90.9 %) respectively. The overall diagnostic performance of sonar guided true cut needle biopsy in diagnosis was 97.78 % sensitivity, 98.18% accuracy, and 100 % PPV

Diagnostic Test: Ultrasound Guided Peripheral Thoracic Tumors

Interventions

Transthoracic ultrasonography: Transthoracic US was done using machine Hitachi 5500 in the Diagnostic Ultrasound Unit - Chest Department- Kasr El-Aini Hospital.on 60 patients that had radiographic evidence of thoracic mass suspected of malignancy

ultra sound guided percutaneous core needle biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • An acoustic window for the ultrasound beam to penetrate.
  • Patients have platelet count more than 100000 and normal prothrombin time.

You may not qualify if:

  • Cardio vascular instability.
  • Arterio venous malformation or aneurysm.
  • Patients with uncontrolled convulsions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef Unversity

Banī Suwayf, 8776, Egypt

Location

Related Publications (8)

  • Rivera MP, Detterbeck F, Mehta AC; American College of Chest Physicians. Diagnosis of lung cancer: the guidelines. Chest. 2003 Jan;123(1 Suppl):129S-136S. doi: 10.1378/chest.123.1_suppl.129s.

  • Chira R, Chira A, Mircea PA. Intrathoracic tumors in contact with the chest wall--ultrasonographic and computed tomography comparative evaluation. Med Ultrason. 2012 Jun;14(2):115-9.

  • Balik M, Plasil P, Waldauf P, Pazout J, Fric M, Otahal M, Pachl J. Ultrasound estimation of volume of pleural fluid in mechanically ventilated patients. Intensive Care Med. 2006 Feb;32(2):318. doi: 10.1007/s00134-005-0024-2. Epub 2006 Jan 24.

  • Diacon AH, Theron J, Schubert P, Brundyn K, Louw M, Wright CA, Bolliger CT. Ultrasound-assisted transthoracic biopsy: fine-needle aspiration or cutting-needle biopsy? Eur Respir J. 2007 Feb;29(2):357-62. doi: 10.1183/09031936.00077706. Epub 2006 Nov 1.

  • Chira RI, Chira A, Mircea PA, Valean S. Mediastinal masses-transthoracic ultrasonography aspects. Medicine (Baltimore). 2017 Dec;96(49):e9082. doi: 10.1097/MD.0000000000009082.

  • Hafez MR, Sobh ES, Elsawy SB, Abo-Elkheir OI. The usefulness of thoracic ultrasonography in diagnosis and staging of bronchogenic carcinoma. Ultrasound. 2017 Nov;25(4):200-212. doi: 10.1177/1742271X17721264. Epub 2017 Aug 3.

  • Schubert P, Wright CA, Louw M, Brundyn K, Theron J, Bolliger CT, Diacon AH. Ultrasound-assisted transthoracic biopsy: cells or sections? Diagn Cytopathol. 2005 Oct;33(4):233-7. doi: 10.1002/dc.20342.

  • Yang PC, Luh KT, Chang DB, Wu HD, Yu CJ, Kuo SH. Value of sonography in determining the nature of pleural effusion: analysis of 320 cases. AJR Am J Roentgenol. 1992 Jul;159(1):29-33. doi: 10.2214/ajr.159.1.1609716.

MeSH Terms

Conditions

Thoracic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • maha fathy, MD of chest

    beni seuf unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The current study is a case series study conducted on 60 patients that had radiographic evidence of thoracic mass suspected of malignancy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of chest

Study Record Dates

First Submitted

October 17, 2020

First Posted

February 5, 2021

Study Start

September 12, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Locations