Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; Myeloproliferative Neoplasm; Prefibrotic/Early Primary Myelofibrosis
• Intervention / Treatment: Diagnostic test: ULTRASOUND EXAM AND MRI SCAN

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective, non-interventional study. Data were retrospectively collected from all patients who completed US and MRI scans

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): March 20, 2024

Study Registration Dates

• First Submitted: April 14, 2024
• First Submitted That Met QC Criteria: April 14, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Ultrasound; Essential Thrombocythemia; Myeloproliferative Neoplasm; Primary Myelofibrosis; Polycythemia Vera; spleen; Prefibrotic/Early Primary Myelofibrosis
• Additional Relevant MeSH Terms: Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms; Primary Myelofibrosis; Thrombocytosis; Thrombocythemia, Essential; Myeloproliferative Disorders; Polycythemia Vera; Polycythemia
• Other Study ID Numbers: MPN-USspleen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No