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

April 5, 2016 updated by: Chengcheng Liao, Guangxi Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanning, China
        • Recruiting
        • Affiliated Tumor Hospital，Guangxi Medical University
        • Contact:
          • LI lequn, MD
        • Principal Investigator:
          • Liao chengcheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lymphoma
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 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.
Other Names:
  • MRI
Device: 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.
Other Names:
  • PET/CT
Radiation: fludeoxyglucose F 18
Patients fasted for 6 h before receiving FDG intravenously. A dose of 5.18-7.4 MBq/kg was used.
Other Names:
  • FDG
  • 18F-FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-FDG uptake in lymphomas with PET/CT
Time Frame: Within 30 days prior to start of chemotherapy
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
Time Frame: Within 30 days prior to start of chemotherapy
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
Time Frame: 2 weeks after the 4th cycle of chemotherapy
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 Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 12 months
12 months
Progression Free Survival
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET-MRI/lymphoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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