PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official 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

Conditions
-----------------
Lymphoma, Bone Marrow Neoplasm

Intervention / Treatment
-----------------
* Procedure: PET Guided Bone Marrow Biopsy
* Procedure: Trephine Bone Marrow Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PET Guided Bone Marrow Biopsy|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|
|Procedure: Trephine Bone Marrow Biopsy|All the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy | 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. | three months |