LymphomaNCT05186610
FDG PET/CT and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma
An observational study of Lymphoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- FDG PET/CT guided metabolic core needle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2017to 31 Aug 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Nuclear Medicine, PGIMER
Chandigarh, Chandigarh, 160012
About this study
Official title: 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.
Read the 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
- Lymphoma
- Being tested
- FDG PET/CT guided metabolic core needle biopsy
- Keywords
- Positron Emission Tomography Computed Tomography, Image-Guided Biopsy, Fluorodeoxyglucose F18, Biopsy-Core Needle
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CT guided metabolic core needle biopsyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: FDG PET/CT guided metabolic core needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Oct 2017
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Rajender Kumar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186610
- Sponsor's protocol ID
- NK/1702/MD/11449-50
- Status last verified
- Feb 2023
- First submitted
- 29 Dec 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be made available on reasonable request for a period of five years from the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography and Directed Metabolic Core Needle Biopsy in the Management of Lymphoma
- ClinicalTrials.gov ID
- NCT05186610
- Acronym / sponsor ID
- NK/1702/MD/11449-50
- Conditions
- Lymphoma
- Keywords
- Positron Emission Tomography Computed Tomography, Image-Guided Biopsy, Fluorodeoxyglucose F18, Biopsy-Core Needle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG PET/CT guided metabolic core needle biopsy group | – | Procedure: FDG PET/CT guided metabolic core needle biopsy2- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG 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). | Procedure or surgery | FDG PET/CT guided metabolic core needle biopsy group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be made available on reasonable request for a period of five years from the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajender Kumar, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The yield of FDG PET/CT guided metabolic biopsy in lymphoma (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.