Clinical trial NCT05565898: PET/CT Vs Bone Marrow Biopsy in Exclusion of Bone Marrow Infiltration for Initial Staging of Lymphoma
Official title: Diagnostic Performance of PET/CT Vs Bone Marrow Biopsy in Exclusion of BM Infiltration for Initial Staging of Lymphoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma
Keywords: lymphoma
PET/CT
Bone Marrow
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient Intially diagnosed with lymphoma

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison between PET/CT and BMB in detection of bone marrow involvement
timeFrame: 30 days between initial bone marrow biopsy and initial PET/CT before starting treatment for lymphoma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
name: Taha Z. Mohran, M.D
role: STUDY_CHAIR
affiliation: Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
name: Nahla M Mahmoud, M.D
role: STUDY_DIRECTOR
affiliation: Assiut university- Faculty of Medicine-Department of Clinical Oncology and Nuclear Medicine
name: Maha Kh Mahmoud, M.D
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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citation: 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.