PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.

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Key information

Conditions

Lymphoma Bone Marrow Diseases Bone Marrow Neoplasm Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine, PGIMER

Chandigarh, 160012, India

About this study

Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newly diagnosed cases of lymphoma (both HL and NHL).
Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
Aged between 18 -80 years.
Informed consent prior to the procedure.

Exclusion criteria

Previously treated/relapsed lymphoma.
Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
Patients who underwent a prior BMTB to evaluate the role of BMI.
Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR > 1.2 and platelet counts < 50,000/mm3,
Patients who refuse to provide informed consent.
No 18F FDG avid skeletal lesions.
Pregnant/Lactating female patients.
Non-cooperative patients.

Treatment and study plan

PET Guided Bone Marrow Biopsy

Procedure

The results of PET/CT images were discussed with the referring physician. PET/CT targeted metabolic marrow biopsy was planned two hours after the whole body diagnostic imaging or on a subsequent day one hour after injecting 2-3 mCi of FDG to minimize the radiation exposure burden to the interventionist.

Society of Interventional Consensus guidelines was followed for image-guided biopsy.

The bone marrow biopsy was done under the PET/CT guidance using the same PET/CT scanner with the help of an automated robotic arm (ARA) workstation

Trephine Bone Marrow Biopsy

Procedure

All the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning.

Primary outcomes

Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy

Time frame: three months

The final diagnosis of bone marrow infiltration was based on the pathology findings of trephine bone marrow biopsy and FDG PET/CT targeted bone marrow biopsy.

The diagnostic accuracy (in percentage) of FDG PET/CT guided metabolic bone marrow biopsy was compared with the accuracy (in percentage) of trephine bone marrow biopsy with respect to final diagnosis.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Role of FDG PET/CT Guided Bone Marrow Biopsy vs. Conventional Bone Marrow Trephine Biopsy for Assessing the Bone Marrow Infiltration in Newly Diagnosed Lymphoma

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: Feb 22, 2022
Registry last updated: Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed