Positron-Emission TomographyNCT05411250
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma
An observational study of Positron-Emission Tomography, run by Peking University Cancer Hospital & Institute.
Trial summary
To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method. 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
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 Jul 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 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
- No previous history of heart disease.
- normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.
- 3.18F-FDG PET/CT examination before and after treatment
- -
Who cannot join
- 1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.
- -
Trial locations and contacts
No sites are listed yet.
About this study
To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.
Read the detailed description
First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.
- Conditions
- Positron-Emission Tomography
- Keywords
- cardiotoxicity, early
- Medical subject headings
- Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
the standardized uptake value
Measured: 150 days
Secondary outcomes (1)
SUVR
the ratio of the standardized uptake value for the heart to the normal tissue such as hepatic blood poor and gluteus
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 posted9 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 Jul 2023 (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
- 40 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 cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411250
- Sponsor's protocol ID
- XW-Heart-002
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma
- ClinicalTrials.gov ID
- NCT05411250
- Acronym / sponsor ID
- XW-Heart-002
- Conditions
- Positron-Emission Tomography
- Keywords
- cardiotoxicity, early
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 9 Jun 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.
To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.
Detailed description
First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
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)
- No previous history of heart disease.
- normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.
- 3.18F-FDG PET/CT examination before and after treatment
- -
Key exclusion criteria (2 listed)
- 1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.
- -
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
the standardized uptake value
1 secondary outcome
SUVR
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 9 Jun 2022.
- 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 cancer hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Positron-Emission Tomography, run by Peking University Cancer Hospital & Institute.
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 2 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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 (8601088196363, 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?
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 9 Jun 2022.