Clinical Trials Directory

Trials / Completed

CompletedNCT05186610

FDG PET/CT and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma

Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma

Status
Completed
Phase
Study type
Observational
Enrollment
480 (actual)
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

FDG-PET/CT is an established modality in various stages of management of lymphoma but definitive information regarding the diagnosis, prognostication, and further management is provided by histopathological examination. Combining the two modalities may provide an incremental benefit by identifying better sites for targetting biopsy and for better verification of sites and causes of FDG uptake seen during PET/CT.

Detailed description

Written informed consent was obtained from all the participants for PET/CT-guided biopsy. The procedure details, related risks, and benefits were explained to all the participants. A multidisciplinary team including hemato-oncologists, nuclear medicine physicians, and pathologists were involved in the project. A hemato-oncologist decided the biopsy indication after discussing it with the nuclear medicine physician. FDG avid lesions in a clinically suspected case of lymphoma or a suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma were sampled. The per and post-procedural complications and management were maintained in the institutional PET data registry and the final histopathological diagnosis obtained was also collected.

Conditions

Interventions

TypeNameDescription
PROCEDUREFDG PET/CT guided metabolic core needle biopsyThe target lesion to be biopsied was chosen based on accessibility and the highest metabolic activity (Highest standardized uptake value) on FDG PET/CT imaging. The final needle course was based on the anatomic location of the lesion, FDG avidity, and its relation with vital organs. The procedures were performed under full aseptic precautions and under adequate local anesthesia. The biopsy needle was placed to the target lesion using an automated robotic arm (ARA) workstation (ROBIO-EX, Perfint healthcare Pvt Ltd, Chennai, India).

Timeline

Start date
2017-10-01
Primary completion
2022-08-31
Completion
2022-08-31
First posted
2022-01-11
Last updated
2023-02-14

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT05186610. Inclusion in this directory is not an endorsement.