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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186610
• Other study ID #: NK/1702/MD/11449-50
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Lymphoma

Intervention

Procedure:
• FDG PET/CT guided metabolic core needle biopsy
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).

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	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