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

NCT05565898 | Unknown

• 1 other identifier: PET/CT In lymphoma
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma

Keywords

lymphoma; PET/CT; Bone Marrow

Outcome Measures

Primary Outcomes (1)

• Comparison between PET/CT and BMB in detection of bone marrow involvement

  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

Interventions

positron emission tomography for exclusion of bone marrow infiltration in lymphoma DEVICE

compare the diagnostic accuracy of PET/CT scan against Bone Marrow Biopsy in detection of bone marrow involvement for staging of lymphoma

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient Intially diagnosed with lymphoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 26314440 BACKGROUND

• 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.

  PMID: 28982893 BACKGROUND

• 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.

  PMID: 28295218 BACKGROUND

• 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.

  PMID: 23674577 BACKGROUND

• 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.

  PMID: 19243321 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow biopsy pathology

MeSH Terms

Conditions

Lymphoma

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Taha Z. Mohran, M.D

  Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Seham Sharef

CONTACT

+201097515105; Seham.14224009@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share