MRI Compared to PET/CT for Staging and Treatment Response in Lymphoma

Lymphoma Clinical Trial

Official title:

Research on the Lymphoma Staging and Therapeutic Evaluation of 18F-FDG PET/CT Comparing With Whole Body MRI IVIM Functional Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733887
• Other study ID #: PET-MRI/lymphoma
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2016
• Last updated: April 5, 2016
• Start date: February 2016

Study information

• Verified date: April 2016
• Source: Guangxi Medical University
• Contact: Chengcheng Liao, MD
• Phone: +8615907817794
• Email: 148804[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma

Intervention

Device:
• magnetic resonance imaging
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.
• positron emission tomography/computed tomography
18F-FDG-PET/CT was performed using a multidetector PET/CT system (GE Discovery ST16). Patients fasted for 6 hours before imaging.

Radiation:
• fludeoxyglucose F 18
Patients fasted for 6 h before receiving FDG intravenously. A dose of 5.18-7.4 MBq/kg was used.

Locations

Country	Name	City	State
China	Affiliated Tumor Hospital,Guangxi Medical University	Nanning

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Español de Médula Ósea; 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days prior to start of chemotherapy	No
Primary	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.	Within 30 days prior to start of chemotherapy	No
Primary	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	2 weeks after the 4th cycle of chemotherapy	No
Secondary	Overall Survival		12 months	No
Secondary	Progression Free Survival		6 months	No