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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05565898
• Other study ID #: PET/CT In lymphoma
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: November 2025

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Seham Sharef
• Phone: +201097515105
• Email: Seham.14224009[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Device:
• positron emission tomography for exclusion of bone marrow infiltration in lymphoma
compare the diagnostic accuracy of PET/CT scan against Bone Marrow Biopsy in detection of bone marrow involvement for staging of lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

Lidén Y, Landgren O, Arnér S, Sjölund 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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