LymphomaPMRILNCT03973164
The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma
An observational study of Lymphoma, run by Guangxi Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Lymphoma
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2018to 22 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population was an Asian race with lymphoma.
Who may be able to join
- 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).
Who cannot join
- Pregnancy, general contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion
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.
- Conditions
- Lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days prior to start of chemotherapy
Secondary outcomes (1)
Agreement Between MRI and 18F-FDG PET/CT at Diagnosis
Region based agreement (%; kappa value) of MRI with 18F-FDG PET/CT at diagnosis.
Measured: Within 30 days prior to start of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start2 Feb 2018
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengcheng Liao, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973164
- Sponsor's protocol ID
- Pelvic MRI/lymphoma
- Acronym
- PMRIL
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25113771
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion
- ClinicalTrials.gov ID
- NCT03973164
- Acronym / sponsor ID
- PMRIL / Pelvic MRI/lymphoma
- Conditions
- Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population was an Asian race with lymphoma.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Pregnancy, general contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between MRI and Bone marrow cytology, pathology and follow-up at Diagnosis
Time frame: Within 30 days prior to start of chemotherapy
MRI-positive lesions that cannot be confirmed by bone marrow cytology and pathology will be confirmed by MRI follow-up.
1 secondary outcome
Agreement Between MRI and 18F-FDG PET/CT at Diagnosis
Time frame: Within 30 days prior to start of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Background: PubMed 25113771Barrington 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between MRI and Bone marrow cytology, pathology and follow-up at Diagnosis (time frame: Within 30 days prior to start of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03973164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.