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出境医 / 临床实验 / The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma (PMRIL)
The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma (PMRIL)
Study Description
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.
| Condition or disease |
|---|
| Lymphoma |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 142 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion |
| Actual Study Start Date : | February 2, 2018 |
| Actual Primary Completion Date : | May 22, 2019 |
| Actual Study Completion Date : | May 22, 2019 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Agreement Between MRI and 18F-FDG PET/CT at Diagnosis [ Time Frame: Within 30 days prior to start of chemotherapy ]Region based agreement (%; kappa value) of MRI with 18F-FDG PET/CT at diagnosis.
Eligibility Criteria
| Ages Eligible for Study: | 8 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The study population was an Asian race with lymphoma.
Criteria
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.
Contacts and Locations
Locations
| China | |
| Affiliated Tumor Hospital，Guangxi Medical University | |
| Nanning, China | |
Sponsors and Collaborators
Guangxi Medical University
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 1, 2019 | ||||
| First Posted Date | June 4, 2019 | ||||
| Last Update Posted Date | June 4, 2019 | ||||
| Actual Study Start Date | February 2, 2018 | ||||
| Actual Primary Completion Date | May 22, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
Agreement Between MRI and 18F-FDG PET/CT at Diagnosis [ Time Frame: Within 30 days prior to start of chemotherapy ] Region based agreement (%; kappa value) of MRI with 18F-FDG PET/CT at diagnosis.
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Value of Pelvic Magnetic Resonance Imaging in Detecting Bone Marrow Infiltration of Lymphoma | ||||
| Official Title | Bone Marrow Cytology, Pathology and 18F-FDG PET/CT and Pelvic MRI in the Diagnosis of Lymphoma Bone Marrow Invasion | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | The study population was an Asian race with lymphoma. | ||||
| Condition | Lymphoma | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
142 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | May 22, 2019 | ||||
| Actual Primary Completion Date | May 22, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • Pregnancy, general contraindications to MRI. |
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| Sex/Gender |
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| Ages | 8 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03973164 | ||||
| Other Study ID Numbers | Pelvic MRI/lymphoma | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Chengcheng Liao, Guangxi Medical University | ||||
| Study Sponsor | Guangxi Medical University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Guangxi Medical University | ||||
| Verification Date | June 2019 | ||||
