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
| Type | Name | Description |
|---|---|---|
| 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 |
| PROCEDURE | Trephine Bone Marrow Biopsy | All 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.