Primary MyelofibrosisNCT06151119
68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
An observational study of Primary Myelofibrosis, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades. To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Myelofibrosis
- What is being tested?
- 68Ga FAPI PET/CT
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Chinese people
Who may be able to join
- Age ≥18 years old;
- Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
- The expected survival time is over 3 months
- Voluntarily sign informed consent.
- Willing and able to follow the research protocol;
- The subject must be able to lie on the scanning bed for 20 minutes;
Who cannot join
- Known allergic history to 68Ga FAPI or its excipients;
- Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
- pregnant and lactating women;
- Workers who are exposed to radiation for a long period of time;
- Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis;
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- Participating in other interventional clinical trials within 1 month before screening;
- Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers;
- There are other circumstances that the researcher thinks are not suitable for participating in this study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bing Xu
Xiamen, Fujian, 361000
Bing Xu, +8618750918842, xubingzhangjian@126.com
Long Liu, +8615160007832, kucangyaoren@126.com
About this study
Official title: A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
To evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.
Read the detailed description
This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
- Conditions
- Primary Myelofibrosis
- Being tested
- 68Ga FAPI PET/CT
- Keywords
- Myelofibrosis, positron emission tomography / computed tomography
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga FAPI PET/CTDiagnostic test
68Ga FAPI PET/CT
| Study group | Role | What they receive |
|---|---|---|
| suspected or confirmed myelofibrosis | Patients with suspected or confirmed myelofibrosis; Receives: Diagnostic Test: 68Ga FAPI PET/CT | |
| primary/secondary myelofibrosis | Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib. Receives: Diagnostic Test: 68Ga FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Measured: Up to 24 months
Specificity
Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Measured: Up to 24 months
Positive prediction rate
Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Measured: Up to 24 months
Negative prediction rate
Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start22 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary MyelofibrosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing, Xu, The First Affiliated Hospital of Xiamen University
- Investigators
- Bing Xu, Principal investigator, The First Aiffiliated hosptical of xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151119
- Sponsor's protocol ID
- XMDYYYXYK-06
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
- ClinicalTrials.gov ID
- NCT06151119
- Acronym / sponsor ID
- XMDYYYXYK-06
- Conditions
- Primary Myelofibrosis
- Keywords
- Myelofibrosis, positron emission tomography / computed tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Nov 2023 (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 evaluate the diagnostic efficacy of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
To evaluate the diagnostic efficacy of 68Ga FAPIPET/CT imaging in patients with myelofibrosis, compared with conventional CT.
Detailed description
This study uses bone marrow biopsy as a gold standard or reference standard to evaluate the diagnostic efficacy (Sensitivity, Specificity, Positive prediction rate, Negative prediction rate) of 68Ga FAPI PET/CT in myelofibrosis and to identify fibrosis grades.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suspected or confirmed myelofibrosis | – | Diagnostic Test: 68Ga FAPI PET/CTPatients with suspected or confirmed myelofibrosis; |
| primary/secondary myelofibrosis | – | Diagnostic Test: 68Ga FAPI PET/CTPatients with primary/secondary myelofibrosis who were not treated with ruxolitinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Chinese people
Key inclusion criteria (6 listed)
- Age ≥18 years old;
- Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.
- The expected survival time is over 3 months
- Voluntarily sign informed consent.
- Willing and able to follow the research protocol;
Key exclusion criteria (9 listed)
- Known allergic history to 68Ga FAPI or its excipients;
- Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history);
- Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia;
- pregnant and lactating women;
- Workers who are exposed to radiation for a long period of time;
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 |
|---|---|---|
| 68Ga FAPI PET/CT68Ga FAPI PET/CT | Diagnostic test | primary/secondary myelofibrosis, suspected or confirmed myelofibrosis |
Primary outcome
Sensitivity
Time frame: Up to 24 months
Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Specificity
Time frame: Up to 24 months
Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Positive prediction rate
Time frame: Up to 24 months
Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Negative prediction rate
Time frame: Up to 24 months
Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Primary Myelofibrosis
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A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
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.
Bing Xu principal investigator
The First Aiffiliated hosptical of xiamen University
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 Primary Myelofibrosis, run by The First Affiliated Hospital of Xiamen University 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Xu (+8618750918842, xubingzhangjian@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Up to 24 months). The study lists 4 primary outcomes in all. 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 19 Feb 2025.