Positron-Emission TomographyNCT04555642
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
An observational study of Positron-Emission Tomography and Magnetic Resonance Imaging, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Positron-Emission Tomography, Magnetic Resonance Imaging
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 28 Feb 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with malignant tumor after chemotherapy or immunotherapy
Who may be able to join
- availability of a clinical pre- and post-therapy clinical evaluation encompassing electrocardiogram (ECG) ;
- normal findings at pre-therapy clinical evaluation;
- cancer planned chemotherapy or immunotherapy scheme ;
- available staging FDG-PET/CT scan (PET0);
Who cannot join
- cannot lie supine for half an hour;
- refuse to join the clinical researcher;
- without metal implants.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Xuejuan Wang, MD, 86 10-88196363, xuejuan_wang@hotmail.com
About this study
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.
Read the detailed description
In this study investigators evaluated cardiac uptake by different molecular probe such as FDG, FAPI-04 using multimodality PET/MRI. Previous studies have shown that increased cardiac uptake of FDG on PET may be an indicator of myocardial injury after chemotherapy. Cardiac magnetic resonance (CMR) allows for multiparametric evaluation of cardiac morphology, ventricular function, myocardial perfusion, and viability. The combination of PET with MR (PET/MR) is therefore an alternative attractive pairing for diagnostic imaging. The aim of this study is to find noninvasive and effective method for early diagnosis of cardiotoxicity after chemotherapy or immunotherapy
- Keywords
- Positron-Emission Tomography, cardiotoxicity, Magnetic Resonance Imaging, FDG, FAPI
- Medical subject headings
- Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| therapy group | lymphoma patients planned chemotherapy or immunotherapy scheme | |
| healthy control group | Inclusion criteria for the controls were no known diseases or syndromes, within the age range from 18 to 35 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVR
the ratio of the standardized uptake value(SUVR) of multi-tracer for the heart within each time window to that of the normal tissue such as hepatic blood pool、blood pool and gluteus.
Measured: 150 days
Secondary outcomes (1)
Change Of Mapping Value and LVEF From Baseline
The change of mapping value and left ventricular ejection fraction between the value before treatment and the value after treatment was calculated based on cardiac magnetic resonance
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 posted21 Sep 2020
- Study start15 Sep 2020
- Primary completion28 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuejuan Wang,MD, Peking University Cancer Hospital & Institute
- Investigators
- Zhi Yang, PhD, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555642
- Sponsor's protocol ID
- XW-Heart-001
- Status last verified
- Feb 2021
- First submitted
- 31 Aug 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
- ClinicalTrials.gov ID
- NCT04555642
- Acronym / sponsor ID
- XW-Heart-001
- Keywords
- Positron-Emission Tomography, cardiotoxicity, Magnetic Resonance Imaging, FDG, FAPI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 28 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 21 Sep 2020 (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.
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.
Detailed description
In this study investigators evaluated cardiac uptake by different molecular probe such as FDG, FAPI-04 using multimodality PET/MRI. Previous studies have shown that increased cardiac uptake of FDG on PET may be an indicator of myocardial injury after chemotherapy. Cardiac magnetic resonance (CMR) allows for multiparametric evaluation of cardiac morphology, ventricular function, myocardial perfusion, and viability. The combination of PET with MR (PET/MR) is therefore an alternative attractive pairing for diagnostic imaging. The aim of this study is to find noninvasive and effective method for early diagnosis of cardiotoxicity after chemotherapy or immunotherapy
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapy group | – | –lymphoma patients planned chemotherapy or immunotherapy scheme |
| healthy control group | – | –Inclusion criteria for the controls were no known diseases or syndromes, within the age range from 18 to 35 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with malignant tumor after chemotherapy or immunotherapy
Key inclusion criteria (4 listed)
- availability of a clinical pre- and post-therapy clinical evaluation encompassing electrocardiogram (ECG) ;
- normal findings at pre-therapy clinical evaluation;
- cancer planned chemotherapy or immunotherapy scheme ;
- available staging FDG-PET/CT scan (PET0);
Key exclusion criteria (3 listed)
- cannot lie supine for half an hour;
- refuse to join the clinical researcher;
- without metal implants.
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
SUVR
Time frame: 150 days
the ratio of the standardized uptake value(SUVR) of multi-tracer for the heart within each time window to that of the normal tissue such as hepatic blood pool、blood pool and gluteus.
1 secondary outcome
Change Of Mapping Value and LVEF From Baseline
Time frame: 150 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Positron-Emission Tomography
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
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 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 Positron-Emission Tomography and Magnetic Resonance Imaging, 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 4 inclusion and 3 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 26 Feb 2021. 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?
SUVR (time frame: 150 days). 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 26 Feb 2021.