PET/CT Vs Bone Marrow Biopsy in Exclusion of Bone Marrow Infiltration for Initial Staging of Lymphoma
October 28, 2022 updated by: Seham Sharef Eid Ahmed, Assiut University
Diagnostic Performance of PET/CT Vs Bone Marrow Biopsy in Exclusion of BM Infiltration for Initial Staging of Lymphoma
lymphoma is a common malignancy in the developed world.
the two main categories of lymphoma are non-Hodgkin lymphoma and non-Hodgkin lymphoma.
Bone marrow biopsy (BMB) is the most direct method of detecting lymphoma infiltration, however it is an invasive procedure.
18 fluro-2deoxy-D glucose PET/CT is a non-invasive examination that can comperhensively evaluate the state of bone marrow (BM) with extremely high sensitivity in detecting bone marrow infiltration of lymphoma.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Lymphoma is a common malignancy in the developed world. Many subtypes of lymphomas are known. The two main categories of lymphoma are the non-Hodgkin lymphoma (NHL) (90% of cases) and Hodgkin lymphoma (HL) (10%). Lymphoma makes up 3-4% of all cancers, making them as a group the seventh-most common form.
Bone marrow biopsy is the most direct method of detecting lymphoma infiltration, however, it is an invasive procedure which is accompanied by several complications such as pain, hemorrhage and may miss marrow involvement if infiltration is patchy, or not taken from a part of the marrow that is involved.
18fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) is a non-invasive examination that can comprehensively evaluate the state of bone marrow with extremely high sensitivity in detecting bone marrow infiltration of lymphoma and can replace bone marrow biopsy.
At this moment, there is no clear international guideline between the indications of PET-CT and bone marrow biopsy, but there is interest in using the PET/CT findings to either supplement or even replace the BMB in the evaluation of BM involvement in lymphoma.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Seham Sharef
- Phone Number: +201097515105
- Email: Seham.14224009@med.aun.edu.eg
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
2 years to 76 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patient Intially diagnosed with lymphoma
Description
Inclusion Criteria:
- Initial diagnosed patient not receiving treatment.
- Baseline bone marrow biopsy.
- Baseline PET/CT.
- The period between performing PET/CT and bone marrow biopsy is maximum 30 days and without lymphoma treatment between the studies.
Exclusion Criteria:
- Patient receiving chemotherapy or corticosteroid before doing PET/CT and BMB.
- patients with known concomitant malignancy.
- patients who received hemopoietic growth factor injections less than 48 hours before the PET/CT.
- patients with previously known and treated lymphoma.
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison between PET/CT and BMB in detection of bone marrow involvement
Time Frame: 30 days between initial bone marrow biopsy and initial PET/CT before starting treatment for lymphoma
|
Compare the diagnostic accuracy of PET/CT scan against Bone Marrow Biopsy in detection of bone marrow involvement for staging of lymphoma.
|
30 days between initial bone marrow biopsy and initial PET/CT before starting treatment for lymphoma
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Taha Z. Mohran, M.D, Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
- Study Director: Nahla M Mahmoud, M.D, Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
- Study Director: Maha Kh Mahmoud, M.D, Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
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
- Tang HJ. [PET/CT Image Values in Clinical Staging of the Patients with Non-Hodgkin's Lymphoma]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2015 Aug;23(4):1030-3. doi: 10.7534/j.issn.1009-2137.2015.04.024. Chinese.
- Angelopoulou MK, Mosa E, Pangalis GA, Rondogianni P, Chatziioannou S, Prassopoulos V, Moschogianni M, Tsirkinidis P, Asimakopoulos JV, Konstantinou I, Tsourouflis G, Sachanas S, Yiakoumis X, Boutsikas G, Arapaki M, Gainaru G, Kyrtsonis MC, Siakantaris MP, Datseris I, Panayiotidis P, Konstantopoulos K, Vassilakopoulos TP. The Significance of PET/CT in the Initial Staging of Hodgkin Lymphoma: Experience Outside Clinical Trials. Anticancer Res. 2017 Oct;37(10):5727-5736. doi: 10.21873/anticanres.12011.
- Metser U, Dudebout J, Baetz T, Hodgson DC, Langer DL, MacCrostie P, Mak V, Tau N. [18 F]-FDG PET/CT in the staging and management of indolent lymphoma: A prospective multicenter PET registry study. Cancer. 2017 Aug 1;123(15):2860-2866. doi: 10.1002/cncr.30672. Epub 2017 Mar 13.
- Berthet L, Cochet A, Kanoun S, Berriolo-Riedinger A, Humbert O, Toubeau M, Dygai-Cochet I, Legouge C, Casasnovas O, Brunotte F. In newly diagnosed diffuse large B-cell lymphoma, determination of bone marrow involvement with 18F-FDG PET/CT provides better diagnostic performance and prognostic stratification than does biopsy. J Nucl Med. 2013 Aug;54(8):1244-50. doi: 10.2967/jnumed.112.114710. Epub 2013 May 14.
- Liden Y, Landgren O, Arner S, Sjolund KF, Johansson E. Procedure-related pain among adult patients with hematologic malignancies. Acta Anaesthesiol Scand. 2009 Mar;53(3):354-63. doi: 10.1111/j.1399-6576.2008.01874.x.
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 (Anticipated)
November 1, 2022
Primary Completion (Anticipated)
November 1, 2024
Study Completion (Anticipated)
November 1, 2025
Study Registration Dates
First Submitted
September 30, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 28, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PET/CT In lymphoma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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