The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma

Lymphoma Clinical Trial

— PMRIL  

Official title:

Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973164
• Other study ID #: Pelvic MRI/lymphoma
• Status: Completed
• Start date: February 2, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: June 2019
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The diagnosis of lymphoma bone marrow infiltration is very important for the staging and treatment mode of lymphoma. Traditional bone marrow cytology and pathology examinations are only performed locally, and missed diagnosis is possible. The study explore the value of multi-parameter pelvic magnetic resonance in detecting bone marrow infiltration with newly diagnosed lymphoma patients . This study also explore the consistency of pelvic magnetic resonance and PET/CT for detection of lymphoma bone marrow infiltration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 22, 2019
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

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 are reference pathologist.

• Patients who gave written informed consent were referred for MRI.

• Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging).

Exclusion Criteria:

• Pregnancy, general contraindications to MRI.

Related Conditions & MeSH terms

• Lymphoma

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)

Barrington SF, Mikhaeel NG, Kostakoglu L, Meignan M, Hutchings M, Müeller SP, Schwartz LH, Zucca E, Fisher RI, Trotman J, Hoekstra OS, Hicks RJ, O'Doherty MJ, Hustinx R, Biggi A, Cheson BD. Role of imaging in the staging and response assessment of lymphoma: consensus of the International Conference on Malignant Lymphomas Imaging Working Group. J Clin Oncol. 2014 Sep 20;32(27):3048-58. Erratum in: J Clin Oncol. 2016 Jul 20;34(21):2562. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement Between MRI and Bone marrow cytology, pathology and follow-up at Diagnosis	MRI-positive lesions that cannot be confirmed by bone marrow cytology and pathology will be confirmed by MRI follow-up.	Within 30 days prior to start of chemotherapy
Secondary	Agreement Between MRI and 18F-FDG PET/CT at Diagnosis	Region based agreement (%; kappa value) of MRI with 18F-FDG PET/CT at diagnosis.	Within 30 days prior to start of chemotherapy