PET/MRINCT05390632
Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas
An observational study of PET/MRI, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- PET/MRI
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to 15 Dec 2023
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients pathologically diagnosed as lymphoma
Who may be able to join
- pathologically diagnosed as lymphoma; Written informed consent for receiving PET/MRI after PET/CT examinations. cancer planned chemotherapy or immunotherapy scheme. expected survival ≥ 12 weeks
Who cannot join
- cannot lie supine for half an hour; refuse to join the clinical researcher; severe liver or kidney dysfunction pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Zhi Yang, PhD contact
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Card Holder's Billing State / Province, 100142
xuetao Chen, MD, 18811175970, chenxuetaoer@163.com
Xue juan Wang, MD, 86 010 88196363, xuejuan_wang@hotmail.com
About this study
Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas
Read the detailed description
In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by 18F-FDG PET (PET/CT and PET/MR). Prior to treatment, all patients will undergo whole-body 18F-FDG PET/CT and PET/MR. The methods' efficiency was compared in the diagnosis of lymph node (LN) and organ involvement.
- Conditions
- PET/MRI
- Keywords
- Positron-Emission Tomography, lymphoma
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
Standardized uptake value of 18F-FDG PET/CT and PET/MRI for target lesion of subject or suspected tumor in each time point window (SUV)
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start15 Oct 2019
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
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 PET/MRIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuejuan Wang, Peking University Cancer Hospital & Institute
- Investigators
- Zhi Yang, PhD, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390632
- Sponsor's protocol ID
- XW-PET/CT &PET/MRI-001
- Status last verified
- Mar 2023
- First submitted
- 22 May 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Yuan T, Wei M, Yu B, Zhou N, Zhu H, Yang Z, Wang X. Diagnostic performance of integrated whole-body 18F-FDG PET/MRI for detecting bone marrow involvement in indolent lymphoma: Comparison with 18F-FDG PET or MRI alone. Front Oncol. 2023 Mar 13;13:1136687. doi: 10.3389/fonc.2023.1136687. eCollection 2023.
PubMed 36994205
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison Between [18F]-FDG PET/CT and PET/MRI in Lymphomas
- ClinicalTrials.gov ID
- NCT05390632
- Acronym / sponsor ID
- XW-PET/CT &PET/MRI-001
- Conditions
- PET/MRI
- Keywords
- Positron-Emission Tomography, lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 25 May 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.
Investigating the performance of 18F-FDG PET/CT and PET/MRI in lymphomas
Detailed description
In this study investigators evaluated Nodal and Extranodal Lymphoma Lesions uptake by 18F-FDG PET (PET/CT and PET/MR). Prior to treatment, all patients will undergo whole-body 18F-FDG PET/CT and PET/MR. The methods' efficiency was compared in the diagnosis of lymph node (LN) and organ involvement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients pathologically diagnosed as lymphoma
Key inclusion criteria (1 listed)
- pathologically diagnosed as lymphoma; Written informed consent for receiving PET/MRI after PET/CT examinations. cancer planned chemotherapy or immunotherapy scheme. expected survival ≥ 12 weeks
Key exclusion criteria (1 listed)
- cannot lie supine for half an hour; refuse to join the clinical researcher; severe liver or kidney dysfunction pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SUVmax
Time frame: 150 days
Standardized uptake value of 18F-FDG PET/CT and PET/MRI for target lesion of subject or suspected tumor in each time point window (SUV)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 36994205Chen X, Yuan T, Wei M, Yu B, Zhou N, Zhu H, Yang Z, Wang X. Diagnostic performance of integrated whole-body 18F-FDG PET/MRI for detecting bone marrow involvement in indolent lymphoma: Comparison with 18F-FDG PET or MRI alone. Front Oncol. 2023 Mar 13;13:1136687. doi: 10.3389/fonc.2023.1136687. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Zhi Yang, PhD contact
Zhi Yang, PhD study director
Peking University Cancer Hospital & Institute
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 PET/MRI, run by Peking University Cancer Hospital & Institute at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuejuan Wang, MD (86 010 88196363, xuejuan_wang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 150 days). 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 NCT05390632, 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 3 Mar 2023.