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PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Conditions

Bone Marrow Neoplasm
Lymphoma

Treatments

Procedure: Trephine Bone Marrow Biopsy
Procedure: PET Guided Bone Marrow Biopsy

Study type

Observational

Funder types

Other

Identifiers

NCT05251168
INT/IEC/2017/1416

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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