NCT02733887

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

March 17, 2016

Last Update Submit

April 5, 2016

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Overall Survival

    12 months

  • Progression Free Survival

    6 months

Study Arms (1)

lymphoma

EXPERIMENTAL

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.

Device: magnetic resonance imagingDevice: positron emission tomography/computed tomographyRadiation: fludeoxyglucose F 18

Interventions

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.

Also known as: MRI
lymphoma

18F-FDG-PET/CT was performed using a multidetector PET/CT system (GE Discovery ST16). Patients fasted for 6 hours before imaging.

Also known as: PET/CT
lymphoma

Patients fasted for 6 h before receiving FDG intravenously. A dose of 5.18-7.4 MBq/kg was used.

Also known as: 18F-FDG, FDG
lymphoma

Eligibility Criteria

Age8 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Pregnancy, general contraindications to MRI, and therapeutic interventions between DWI-MRI and 18F-FDG-PET/CT were used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital,Guangxi Medical University

Nanning, China

RECRUITING

Related 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 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.

    PMID: 25113753BACKGROUND

MeSH Terms

Conditions

Lymphoma

Interventions

Magnetic Resonance ImagingPositron Emission Tomography Computed TomographyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPositron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingDiagnostic Techniques, RadioisotopeDeoxyglucoseDeoxy SugarsCarbohydrates

Central Study Contacts

Chengcheng Liao, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 17, 2016

First Posted

April 12, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2017

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations