PET/CT Vs Bone Marrow Biopsy in Exclusion of Bone Marrow Infiltration for Initial Staging of Lymphoma

Not yet recruiting

• Conditions: Lymphoma

• Registration Number: NCT05565898
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Status Verified: 2022-10
• Study First Posted: 2022-10-04
• Last Update Submitted: 2022-10-28
• Study Start: 2022-11
• Last Update Posted: 2022-11-01
• Primary Completion: 2024-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between PET/CT and BMB in detection of bone marrow involvement	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.