PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05251168
• Other study ID #: INT/IEC/2017/1416
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2022
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 31, 2019
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Lymphoma

Intervention

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
• Trephine Bone Marrow Biopsy
All the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning.

Locations

Country	Name	City	State
India	Department of Nuclear Medicine, PGIMER	Chandigarh	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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