Clinical Trials Directory

Trials / Completed

CompletedNCT05251168

PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy

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

Status
Completed
Phase
Study type
Observational
Enrollment
180 (actual)
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPET Guided Bone Marrow BiopsyThe 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
PROCEDURETrephine Bone Marrow BiopsyAll the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning.

Timeline

Start date
2017-01-01
Primary completion
2018-12-31
Completion
2019-03-31
First posted
2022-02-22
Last updated
2022-02-23

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05251168. Inclusion in this directory is not an endorsement.