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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05251168
Other study ID # INT/IEC/2017/1416
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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