Clinical trial NCT02733887: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: 18F-FDG uptake in lymphomas with PET/CT
timeFrame: Within 30 days prior to start of chemotherapy
measure: Agreement between DWI-MRI and 18F-FDG PET/CT at diagnosis
timeFrame: Within 30 days prior to start of chemotherapy
measure: Agreement between DWI-MRI and 18F-FDG PET/CT in follow-up examinations
timeFrame: 2 weeks after the 4th cycle of chemotherapy
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months
measure: Progression Free Survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: Affiliated Tumor Hospital，Guangxi Medical University
Study officials:
References:
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.