NCT03973164

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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 2, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2019

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 1, 2019

Last Update Submit

June 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Agreement Between MRI and 18F-FDG PET/CT at Diagnosis

    Within 30 days prior to start of chemotherapy

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population was an Asian race with lymphoma.

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 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).

You may not qualify if:

  • Pregnancy, general contraindications to MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Tumor Hospital,Guangxi Medical University

Nanning, China

Location

Related Publications (1)

  • Barrington SF, Mikhaeel NG, Kostakoglu L, Meignan M, Hutchings M, Mueller 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. doi: 10.1200/JCO.2013.53.5229.

    PMID: 25113771BACKGROUND

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2019

First Posted

June 4, 2019

Study Start

February 2, 2018

Primary Completion

May 22, 2019

Study Completion

May 22, 2019

Last Updated

June 4, 2019

Record last verified: 2019-06

Locations