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

February 13, 2023 updated by: Rajender Kumar, Postgraduate Institute of Medical Education and Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Chandīgarh
      • Chandigarh, Chandīgarh, India, 160012
        • Department of Nuclear Medicine, PGIMER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The yield of FDG PET/CT guided metabolic biopsy in lymphoma
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Postgraduate Institute of Medical Education and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rajender Kumar, MD, Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NK/1702/MD/11449-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data will be made available on reasonable request for a period of five years from the end of the study.

IPD Sharing Time Frame

Five years from the end of the study period

IPD Sharing Access Criteria

Will be made available from the principal investigator upon reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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