PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

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

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lymphoma Bone Marrow Neoplasm

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Trephine Bone Marrow Biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No