PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

Completed

• Conditions: Lymphoma; Bone Marrow Neoplasm

• Registration Number: NCT05251168
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Status Verified: 2022-02
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Study First Posted: 2022-02-22
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy	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.

Trial Locations

Locations (1)

Department of Nuclear Medicine, PGIMER; 🇮🇳 Chandigarh, Chandīgarh, India