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出境医 / 临床实验 / Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Patients With Lymphoma

Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Patients With Lymphoma

Study Description
Brief Summary:
  • The goal of this study is to determine the feasibility of the diffusion weighted Magnetic Resonance Imaging in the evaluation of the treatment response in patients with malignant lymphoma.
  • The investigator's objective is to compare the changes of mean Apparent Diffusion Coefficient value of the tumor with the changes of maximum Standardized Uptake Value of the tumor in positron Emission Tomography Computed Tomography in both pre and post therapy status .

Condition or disease Intervention/treatment
Lymphoma Radiation: diffusion weighted magnetic resonance image in lymphoma

Detailed Description:

Lymphomas are the malignant tumors of lymph nodes and considered as one of the most common primary hematopoietic malignancy. Multi slice computed tomography is the most readily available and most commonly used tool for staging lymphoma. But it has multiple limitations in diagnosis of lymphoma as the recognition of lymph node involvement is based only on the size of the lymph node without any metabolic information .

The tumors rely on glucose as their substrate for energy production and replication, this metabolic information can be obtained from the 2-deoxy-2-fluoro-D-glucose Among the positron Emission Tomography Computed Tomography parameters, standardized uptake value is currently the most commonly used semi-quantitative index of 2-deoxy-2-fluoro-D-glucose metabolic rate. standardized uptake value reflects tumor glucose metabolism, and is commonly represented by the maximum standardized uptake value .2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography has been shown to be more accurate for the evaluation of the extent of disease and treatment response by providing these metabolic information in patients with malignant lymphoma .

2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography , with the advantage of being able to perform whole-body detection of malignant lesions, is considered to be the current standard of practice for the management of lymphomas; however, positron Emission Tomography Computed Tomography is expensive, time-consuming, involves exposure to ionizing radiation and is not widely available because it requires large and expensive equipment . In contrast, Magnetic Resonance Imaging provides excellent tissue contrast, high spatial resolution, detailed morphological information without the use of ionizing radiation . Diffusion-weighted Magnetic Resonance Imaging is a noninvasive technique allows visualization of diffusion properties of water molecules in biologic tissues. .

A supplemental tool in Diffusion-weighted imaging is the apparent diffusion coefficient map , acquired by post-processing of the obtained Diffusion-weighted images . apparent diffusion coefficient allows for quantitative definition of diffusion parameters (in mm2/sec) . Diffusion-weighted images with apparent diffusion coefficient mapping could provide useful functional information regarding the characterization of lymphomas .Because of their high cellularity and high nuclear-to-cytoplasm ratio .

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Evaluation of Patients With Malignant Lymphoma: Comparison With 2-deoxy-2-fluoro-D-glucose-positron Emission Tomography/Computed Tomography
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : January 30, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
1 lymphoma patients
pre therapy and post therapy of lymphoma patients
Radiation: diffusion weighted magnetic resonance image in lymphoma
compare between result of positron emission tomography /computed tomography and diffusion weighted imaging in followup of lymphoma

Outcome Measures
Primary Outcome Measures :
  1. role of diffusion weighted imaging in followup of lymphoma [ Time Frame: 5 minutes ]
    • measures mean Apparent diffusion coefficient value in pre and post therapy status in patients with lymphoma with cut off value 1 .


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed as malignant lymphoma
Criteria

Inclusion Criteria:

  • patients clinically diagnosed as lymphoma patient can tolerate the magnetic resonance examination.

Exclusion Criteria:

  • presence of paramagnetic substance as peace maker or cochlear implants and claustrophobia.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Abouzeid Hazem, professor 01005075888 sarad423@yahoo.com
Contact: Khodary Omran, lecturer omranshow@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: sara, Msc Assiut University
Tracking Information
First Submitted Date May 23, 2019
First Posted Date May 31, 2019
Last Update Posted Date May 31, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019)
role of diffusion weighted imaging in followup of lymphoma [ Time Frame: 5 minutes ]
• measures mean Apparent diffusion coefficient value in pre and post therapy status in patients with lymphoma with cut off value 1 .
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Patients With Lymphoma
Official Title Diffusion-weighted Magnetic Resonance Imaging in Post Therapy Evaluation of Patients With Malignant Lymphoma: Comparison With 2-deoxy-2-fluoro-D-glucose-positron Emission Tomography/Computed Tomography
Brief Summary
  • The goal of this study is to determine the feasibility of the diffusion weighted Magnetic Resonance Imaging in the evaluation of the treatment response in patients with malignant lymphoma.
  • The investigator's objective is to compare the changes of mean Apparent Diffusion Coefficient value of the tumor with the changes of maximum Standardized Uptake Value of the tumor in positron Emission Tomography Computed Tomography in both pre and post therapy status .
Detailed Description

Lymphomas are the malignant tumors of lymph nodes and considered as one of the most common primary hematopoietic malignancy. Multi slice computed tomography is the most readily available and most commonly used tool for staging lymphoma. But it has multiple limitations in diagnosis of lymphoma as the recognition of lymph node involvement is based only on the size of the lymph node without any metabolic information .

The tumors rely on glucose as their substrate for energy production and replication, this metabolic information can be obtained from the 2-deoxy-2-fluoro-D-glucose Among the positron Emission Tomography Computed Tomography parameters, standardized uptake value is currently the most commonly used semi-quantitative index of 2-deoxy-2-fluoro-D-glucose metabolic rate. standardized uptake value reflects tumor glucose metabolism, and is commonly represented by the maximum standardized uptake value .2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography has been shown to be more accurate for the evaluation of the extent of disease and treatment response by providing these metabolic information in patients with malignant lymphoma .

2-deoxy-2-fluoro-D-glucose positron Emission Tomography Computed Tomography , with the advantage of being able to perform whole-body detection of malignant lesions, is considered to be the current standard of practice for the management of lymphomas; however, positron Emission Tomography Computed Tomography is expensive, time-consuming, involves exposure to ionizing radiation and is not widely available because it requires large and expensive equipment . In contrast, Magnetic Resonance Imaging provides excellent tissue contrast, high spatial resolution, detailed morphological information without the use of ionizing radiation . Diffusion-weighted Magnetic Resonance Imaging is a noninvasive technique allows visualization of diffusion properties of water molecules in biologic tissues. .

A supplemental tool in Diffusion-weighted imaging is the apparent diffusion coefficient map , acquired by post-processing of the obtained Diffusion-weighted images . apparent diffusion coefficient allows for quantitative definition of diffusion parameters (in mm2/sec) . Diffusion-weighted images with apparent diffusion coefficient mapping could provide useful functional information regarding the characterization of lymphomas .Because of their high cellularity and high nuclear-to-cytoplasm ratio .

Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients diagnosed as malignant lymphoma
Condition Lymphoma
Intervention Radiation: diffusion weighted magnetic resonance image in lymphoma
compare between result of positron emission tomography /computed tomography and diffusion weighted imaging in followup of lymphoma
Study Groups/Cohorts 1 lymphoma patients
pre therapy and post therapy of lymphoma patients
Intervention: Radiation: diffusion weighted magnetic resonance image in lymphoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 30, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients clinically diagnosed as lymphoma patient can tolerate the magnetic resonance examination.

Exclusion Criteria:

  • presence of paramagnetic substance as peace maker or cochlear implants and claustrophobia.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Abouzeid Hazem, professor 01005075888 sarad423@yahoo.com
Contact: Khodary Omran, lecturer omranshow@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03969381
Other Study ID Numbers lymphoma
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sara Ali Gamal, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Principal Investigator: sara, Msc Assiut University
PRS Account Assiut University
Verification Date May 2019