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

NCT05186610 | Completed

• 1 other identifier: NK/1702/MD/11449-50
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma

Keywords

Positron Emission Tomography Computed Tomography; Image-Guided Biopsy; Fluorodeoxyglucose F18; Biopsy-Core Needle

Outcome Measures

Primary Outcomes (1)

• The yield of FDG PET/CT guided metabolic biopsy in lymphoma

  Percentage of biopsy procedures that yielded a sample sufficient for diagnosing the presence or absence of a specific pathology among the patients undergoing the biopsy. Negative biopsy procedures were followed up for a period of one year to confirm the negative findings.

  1 year

Study Arms (1)

FDG PET/CT guided metabolic core needle biopsy group

2- Fluorodeoxyglucose (FDG) PET-positive lesions at initial presentation or at the end of treatment were considered for PET/CT guided biopsy after discussion with the hemato oncologist.

Procedure: FDG PET/CT guided metabolic core needle biopsy

Interventions

FDG PET/CT guided metabolic core needle biopsy PROCEDURE

The 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).

FDG PET/CT guided metabolic core needle biopsy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive participants presenting either with clinical suspicion of lymphomatous etiology at initial documentation or follow-up PET/CT scan during interim evaluation or at the end of therapy in pathologically proven lymphomatous etiology were included. All the patients underwent whole-body FDG PET/CT imaging and the patients with a lesion suspicious for lymphomatous involvement on FDG PET/CT imaging were recruited for PET/CT guided biopsy.

You may qualify if:

• FDG avid lesion in a clinically suspected case of lymphoma.
• Suspicious, residual FDG avid lesion detected at the time of follow-up PET/CT imaging in a patient with a prior diagnosis of lymphoma either at the end-of-treatment or during surveillance.

You may not qualify if:

• Deranged coagulation profile.
• Inaccessibility of the lesion for a percutaneous biopsy.
• Resolution of the lesion at the time of biopsy planning.
• Participant is not willing for the procedure.
• Pregnant females and participants less than 18 years of age.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Department of Nuclear Medicine, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rajender Kumar, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Nuclear Medicine,

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 11, 2022
• Study Start: October 1, 2017
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Five years from the end of the study period
• Access Criteria: Will be made available from the principal investigator upon reasonable request.

Locations

IN (1)