Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms

Primary Myelofibrosis Clinical Trial

Official title:

Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms: Comparison With MRI Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06371573
• Other study ID #: MPN-USspleen
• Status: Completed
• Start date: April 20, 2017
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Adult patients (>18 years) with newly diagnosis of Ph negative myeloproliferative neoplasms (MPNs) according to WHO 2016 criteria, will be recruited to this study.

This study is the result of the collaboration the Hematology Division of Federico II University Medical School of Naples (Italy), that performed the US investigation and the IRCCS SYNLAB SDN where the patients carried out MR. The study is conducted in accordance with the Declaration of Helsinki. All subjects gave informed consent to receive both US and MR scans of the spleen.

All spleen US scans were performed by the same operator (with>10 years of experience in abdominal US), who used an EPIQ 5 Philips instrument with a 1-5 MHz broadband curvilinear probe. The spleen was scanned in patients who were fasting, in the longitudinal and transverse planes by using an intercostal approach, a subcostal approach, or both.

The patient was placed in a supine or right-sided position until complete organ visualization was achieved. Perimeter, longitudinal diameter (LD), and area, defined as the maximum measurements with splenic borders and angles clearly defined, were measured, and SV (in milliliters) was calculated automatically. For each subject, the mean value of 3 measurements repeated on the same imaging session was calculated and recorded for final analysis. Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI). The DWI includes an apparent diffusion coefficient (ADC) map that was automatically generated at the time of acquisition. At last, an isotropic 2mm3 axial Volumetric Interpolated Breath-hold Examination (VIBE) sequence for SV evaluation was acquired. For the latter, attention was paid to optimize the field of view to the spleen, in order to reduce patient's apnea and possible respiratory artifacts. A radiologist with mote than 10 years of experience in abdominal MRI reporting performed measurement of the three orthogonal diameters of the spleen for each patient. Subsequently, SV was calculated using ITK-SNAP software and semi-automatic 3D segmentation approach, firstly based on a signal threshold.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 20, 2024
• Est. primary completion date: January 20, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of Philadelphia (Ph) negative chronic myeloproliferative neoplasms (MPN), according to WHO 2016 criteria

• age >18 years

• execution of MRI of the upper abdomen within two weeks from the US,

Exclusion Criteria:

• patients not fulfilling inclusion criteria

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Prefibrotic/Early Primary Myelofibrosis
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Diagnostic Test:
• ULTRASOUND EXAM AND MRI SCAN
Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI).

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agreement between two different diagnostic methods	Estimation of Spleen Volume and Longitudinal Diameter obtained with US measurement were compared to that obtained using MRI conducted in a time span of 2 weeks	2 weeks