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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05565898
Collaborator
(none)
100
36

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: positron emission tomography for exclusion of bone marrow infiltration in 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Diagnostic Performance of PET/CT Vs Bone Marrow Biopsy in Exclusion of BM Infiltration for Initial Staging of Lymphoma
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Seham Sharef Eid Ahmed, Principle investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05565898
Other Study ID Numbers:
  • PET/CT In lymphoma
First Posted:
Oct 4, 2022
Last Update Posted:
Nov 1, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seham Sharef Eid Ahmed, Principle investigator, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2022