Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371573
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-04-14
Brief Title:
Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms Comparison With MRI Examination
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 with10 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 patients 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
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 with10 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None