LymphomaNCT05251168
PET Guided Bone Marrow Biopsy vs Trephine Bone Marrow Biopsy
An observational study of Lymphoma and Bone Marrow Neoplasm, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma, Bone Marrow Neoplasm
- What is being tested?
- PET Guided Bone Marrow Biopsy and Trephine Bone Marrow Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 31 Mar 2019
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Treatment naïve patients of lymphoma who underwent FDG PET/CT for initial staging were recruited.
Who may be able to join
- Newly diagnosed cases of lymphoma (both HL and NHL).
- Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
- Aged between 18 -80 years.
- Informed consent prior to the procedure.
Who cannot join
- Previously treated/relapsed lymphoma.
- Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
- Patients who underwent a prior BMTB to evaluate the role of BMI.
- Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR > 1.2 and platelet counts < 50,000/mm3,
- Patients who refuse to provide informed consent.
- No 18F FDG avid skeletal lesions.
- Pregnant/Lactating female patients.
- Non-cooperative patients.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Nuclear Medicine, PGIMER
Chandigarh, Chandigarh, 160012
About this study
Official title: Role of FDG PET/CT Guided Bone Marrow Biopsy vs. Conventional Bone Marrow Trephine Biopsy for Assessing the Bone Marrow Infiltration in Newly Diagnosed Lymphoma
Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.
Read the detailed description
Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.
- Conditions
- Lymphoma, Bone Marrow Neoplasm
- Being tested
- PET Guided Bone Marrow Biopsy, Trephine Bone Marrow Biopsy
- Medical subject headings
- Lymphoma, Bone Marrow Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Guided Bone Marrow BiopsyProcedure or surgery
The results of PET/CT images were discussed with the referring physician. PET/CT targeted metabolic marrow biopsy was planned two hours after the whole body diagnostic imaging or on a subsequent day one hour after injecting 2-3 mCi of FDG to minimize the radiation exposure burden to the interventionist.
Society of Interventional Consensus guidelines was followed for image-guided biopsy.
The bone marrow biopsy was done under the PET/CT guidance using the same PET/CT scanner with the help of an automated robotic arm (ARA) workstation
Trephine Bone Marrow BiopsyProcedure or surgery
All the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy
The final diagnosis of bone marrow infiltration was based on the pathology findings of trephine bone marrow biopsy and FDG PET/CT targeted bone marrow biopsy.
The diagnostic accuracy (in percentage) of FDG PET/CT guided metabolic bone marrow biopsy was compared with the accuracy (in percentage) of trephine bone marrow biopsy with respect to final diagnosis.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251168
- Sponsor's protocol ID
- INT/IEC/2017/1416
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol can be shared only on reasonable requests.
Publications
Mahdi RA, Dasagrathi V, Kumar R, Singh H, Mittal BR, Prakash G, Malhotra P, Bal A, Naseem S. Comparison of automated robotic arm-assisted PET/computed tomography-guided metabolic bone marrow biopsy with conventional bone marrow trephine biopsy for evaluating bone marrow infiltration in newly diagnosed lymphoma. Nucl Med Commun. 2026 Sep 1;47(9):1102-1110. doi: 10.1097/MNM.0000000000002170. Epub 2026 May 6.
PubMed 42087722
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of FDG PET/CT Guided Bone Marrow Biopsy vs. Conventional Bone Marrow Trephine Biopsy for Assessing the Bone Marrow Infiltration in Newly Diagnosed Lymphoma
- ClinicalTrials.gov ID
- NCT05251168
- Acronym / sponsor ID
- INT/IEC/2017/1416
- Conditions
- Lymphoma, Bone Marrow Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 22 Feb 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.
Newly diagnosed lymphoma patients were recruited for FDG PET/CT and PET/CT guided bone marrow biopsy. All the patients also underwent routine bone marrow sampling from the posterior superior iliac spine.
Detailed description
Newly diagnosed patients underwent FDG PET/CT for whole-body staging. All the PET/CT images were analyzed by a qualified nuclear medicine physician. The bone marrow FDG uptake was classified as negative, focal, multifocal and diffuse marrow uptake. A PET/CT guided metabolic bone marrow sampling from the FDG avid marrow-based lesion was done. However, patients with diffuse FDG avidity or no uptake in the marrow differed for PET-guided biopsy. All the patients underwent routine trephine bone marrow sampling. Bone marrow infiltration (final diagnosis) was established based on trephine bone marrow sampling and FDG PET/CT targeted bone marrow biopsy results in the present study. The results of both the biopsies were correlated with the final diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Treatment naïve patients of lymphoma who underwent FDG PET/CT for initial staging were recruited.
Key inclusion criteria (4 listed)
- Newly diagnosed cases of lymphoma (both HL and NHL).
- Hypermetabolic bone marrow lesions on staging 18F-FDG PET/CT, which are accessible for biopsy.
- Aged between 18 -80 years.
- Informed consent prior to the procedure.
Key exclusion criteria (8 listed)
- Previously treated/relapsed lymphoma.
- Initiation of therapy (chemotherapy, radiation therapy) and/or hematopoietic growth factor injections before 18F-FDG PET/CT or BMTB.
- Patients who underwent a prior BMTB to evaluate the role of BMI.
- Patients with pre-existing bleeding diatheses like hemophilia, coagulopathy, INR > 1.2 and platelet counts < 50,000/mm3,
- Patients who refuse to provide informed consent.
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 |
|---|---|---|
| PET Guided Bone Marrow BiopsyThe results of PET/CT images were discussed with the referring physician. PET/CT targeted metabolic marrow biopsy was planned two hours after the whole body diagnostic imaging or on a subsequent day one hour after injecting 2-3 mCi of FDG to minimize the radiation exposure burden to the interventionist. Society of Interventional Consensus guidelines was followed for image-guided biopsy. The bone marrow biopsy was done under the PET/CT guidance using the same PET/CT scanner with the help of an automated robotic arm (ARA) workstation | Procedure or surgery | – |
| Trephine Bone Marrow BiopsyAll the participants underwent trephine bone marrow biopsies from the bilateral posterior superior iliac spine before treatment planning. | Procedure or surgery | – |
Primary outcome
Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy
Time frame: three months
The final diagnosis of bone marrow infiltration was based on the pathology findings of trephine bone marrow biopsy and FDG PET/CT targeted bone marrow biopsy. The diagnostic accuracy (in percentage) of FDG PET/CT guided metabolic bone marrow biopsy was compared with the accuracy (in percentage) of trephine bone marrow biopsy with respect to final diagnosis.
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 23 Feb 2022.
- Derived from this study: PubMed 42087722Mahdi RA, Dasagrathi V, Kumar R, Singh H, Mittal BR, Prakash G, Malhotra P, Bal A, Naseem S. Comparison of automated robotic arm-assisted PET/computed tomography-guided metabolic bone marrow biopsy with conventional bone marrow trephine biopsy for evaluating bone marrow infiltration in newly diagnosed lymphoma. Nucl Med Commun. 2026 Sep 1;47(9):1102-1110. doi: 10.1097/MNM.0000000000002170. Epub 2026 May 6.
- Individual participant dataSharing planned: No. Study protocol can be shared only on reasonable requests.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Bone Marrow Neoplasm, 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 4 inclusion and 8 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 23 Feb 2022. 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?
Comparison results of PET guided bone marrow biopsy with trephine bone marrow biopsy (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251168, which also lists 1 linked publication.
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 23 Feb 2022.