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

Sponsor
Postgraduate Institute of Medical Education and Research (Other)
Overall Status
Completed
CT.gov ID
NCT05186610
Collaborator
(none)
213
83

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: FDG PET/CT guided metabolic core needle biopsy

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
213 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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).

Outcome Measures

Primary Outcome Measures

  1. The yield of FDG PET/CT guided metabolic biopsy in lymphoma [1 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Rajender Kumar, MD, Postgraduate Institute of Medical Education and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rajender Kumar, Associate Professor, Department of Nuclear Medicine,, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT05186610
Other Study ID Numbers:
  • NK/1702/MD/11449-50
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rajender Kumar, Associate Professor, Department of Nuclear Medicine,, Postgraduate Institute of Medical Education and Research
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022