MRI Compared to PET/CT for Staging and Treatment Response in Lymphoma
Primary Purpose
Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnetic resonance imaging
positron emission tomography/computed tomography
fludeoxyglucose F 18
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Lymphoma subtypes were diagnosed on the basis of tissue samples obtained by biopsy or surgery according to the criteria outlined in the current World Health Organization (WHO) classification of hematologic and lymphoid malignancies, by a reference pathologist.
- Patients who gave written informed consent were referred for DWI-MRI and 18F-FDG-PET/CT.
- Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging).
Exclusion Criteria:
- Pregnancy, general contraindications to MRI, and therapeutic interventions between DWI-MRI and 18F-FDG-PET/CT were used.
Sites / Locations
- Affiliated Tumor Hospital,Guangxi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lymphoma
Arm Description
The lymph nodes or masses, fludeoxyglucose F18 positron emission tomography/computed tomography(PET/CT) standard uptake value(SUV) results, whole body magnetic resonance imaging(MRI) intravoxel incoherent motion(IVIM) sequence D, D*,f values and MRI volumes of lymphoma were compared before and after the chemotherapy in this project prospectively to provide data for evaluating the dependency and differences of PET/CT and whole body MRI in lymphoma staging and therapeutic evaluation.
Outcomes
Primary Outcome Measures
18F-FDG uptake in lymphomas with PET/CT
Different 18F-FDG uptake values in lymphoma tissue (e.g. SUVmax, SUVmean, binding potential) will be measured and correlated with immunohistochemically determined somatostatin receptor status, lymphoma aggressiveness and tissue biomarkers
Agreement between DWI-MRI and 18F-FDG PET/CT at diagnosis
Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT at diagnosis.
Agreement between DWI-MRI and 18F-FDG PET/CT in follow-up examinations
Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT after completion of chemotherapy for treatment response assessment
Secondary Outcome Measures
Overall Survival
Progression Free Survival
Full Information
NCT ID
NCT02733887
First Posted
March 17, 2016
Last Updated
April 5, 2016
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02733887
Brief Title
MRI Compared to PET/CT for Staging and Treatment Response in Lymphoma
Official Title
Research on the Lymphoma Staging and Therapeutic Evaluation of 18F-FDG PET/CT Comparing With Whole Body MRI IVIM Functional Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT) standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI) intravoxel incoherent motion(IVIM) sequence D, D*, f values and MRI volumes of lymphoma patients were compared before and after the chemotherapy in this project prospectively to provide data for evaluating the dependency and differences of PET/CT and whole body MRI in lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained in follow-up visits of patients such as Overall Survival(OS), Progression Free Survival (PFS) etc. were used to evaluate the diagnostic sensitivity and differences of MRI and PET/CT. The research could provide a new method of nonionizing radiation iconography for physicians to give appropriate treatments and predict prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lymphoma
Arm Type
Experimental
Arm Description
The lymph nodes or masses, fludeoxyglucose F18 positron emission tomography/computed tomography(PET/CT) standard uptake value(SUV) results, whole body magnetic resonance imaging(MRI) intravoxel incoherent motion(IVIM) sequence D, D*,f values and MRI volumes of lymphoma were compared before and after the chemotherapy in this project prospectively to provide data for evaluating the dependency and differences of PET/CT and whole body MRI in lymphoma staging and therapeutic evaluation.
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
MRI was performed on a 3 Tesla system (GE Discovery 750W). A single-shot,echo-planar imaging-based, spectral adiabatic inversion recovery DWI sequence was obtained with b values of 0,30,50,80,100,150,200,400,600,800 and 1,000.
Intervention Type
Device
Intervention Name(s)
positron emission tomography/computed tomography
Other Intervention Name(s)
PET/CT
Intervention Description
18F-FDG-PET/CT was performed using a multidetector PET/CT system (GE Discovery ST16). Patients fasted for 6 hours before imaging.
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
18F-FDG, FDG
Intervention Description
Patients fasted for 6 h before receiving FDG intravenously. A dose of 5.18-7.4 MBq/kg was used.
Primary Outcome Measure Information:
Title
18F-FDG uptake in lymphomas with PET/CT
Description
Different 18F-FDG uptake values in lymphoma tissue (e.g. SUVmax, SUVmean, binding potential) will be measured and correlated with immunohistochemically determined somatostatin receptor status, lymphoma aggressiveness and tissue biomarkers
Time Frame
Within 30 days prior to start of chemotherapy
Title
Agreement between DWI-MRI and 18F-FDG PET/CT at diagnosis
Description
Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT at diagnosis.
Time Frame
Within 30 days prior to start of chemotherapy
Title
Agreement between DWI-MRI and 18F-FDG PET/CT in follow-up examinations
Description
Region based agreement (%; kappa value) of DWI-MRI with 18F-FDG PET/CT after completion of chemotherapy for treatment response assessment
Time Frame
2 weeks after the 4th cycle of chemotherapy
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
12 months
Title
Progression Free Survival
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lymphoma subtypes were diagnosed on the basis of tissue samples obtained by biopsy or surgery according to the criteria outlined in the current World Health Organization (WHO) classification of hematologic and lymphoid malignancies, by a reference pathologist.
Patients who gave written informed consent were referred for DWI-MRI and 18F-FDG-PET/CT.
Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging).
Exclusion Criteria:
Pregnancy, general contraindications to MRI, and therapeutic interventions between DWI-MRI and 18F-FDG-PET/CT were used.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengcheng Liao, MD
Phone
+8615907817794
Email
148804@qq.com
Facility Information:
Facility Name
Affiliated Tumor Hospital,Guangxi Medical University
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI lequn, MD
First Name & Middle Initial & Last Name & Degree
Liao chengcheng, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25113753
Citation
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
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MRI Compared to PET/CT for Staging and Treatment Response in Lymphoma
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