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

NCT ID: NCT05565898

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Seham Sharef Eid Ahmed

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taha Z. Mohran, M.D

Role: STUDY_CHAIR

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

Nahla M Mahmoud, M.D

Role: STUDY_DIRECTOR

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

Maha Kh Mahmoud, M.D

Role: STUDY_DIRECTOR

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

Central Contacts

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Seham Sharef

Role: CONTACT

+201097515105

References

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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.

Reference Type BACKGROUND
PMID: 26314440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28982893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28295218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23674577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19243321 (View on PubMed)

Other Identifiers

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PET/CT In lymphoma

Identifier Type: -

Identifier Source: org_study_id

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