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Trial Title:
PET/CT Vs Bone Marrow Biopsy in Exclusion of Bone Marrow Infiltration for Initial Staging of Lymphoma
NCT ID:
NCT05565898
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Conditions: Keywords:
lymphoma
PET/CT
Bone Marrow
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
positron emission tomography for exclusion of bone marrow infiltration in lymphoma
Description:
compare the diagnostic accuracy of PET/CT scan against Bone Marrow Biopsy in detection of
bone marrow involvement for staging of lymphoma
Summary:
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.
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.
Criteria for eligibility:
Study pop:
patient Intially diagnosed with lymphoma
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
1 Year
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
November 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05565898
