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68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥18 years old; 2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib. 3. The expected survival time is over 3 months. 4. Voluntarily sign informed consent. 5. Willing and able to follow the research protocol; 6. The subject must be able to lie on the scanning bed for 20 minutes;

Exclusion Criteria:

1. Known allergic history to 68Ga FAPI or its excipients; 2. Patients who can not tolerate intravenous drug administration (such as needle fainting and blood fainting history); 3. Those who are not suitable for or unable to complete imaging tests such as PET due to special reasons, including claustrophobia and radiophobia; 4. pregnant and lactating women; 5. Workers who are exposed to radiation for a long period of time; 6. Serious diseases of the heart, kidney, lung, blood vessel, nervous system, mental system, immune deficiency diseases and hepatitis/cirrhosis; 7. Participating in other interventional clinical trials within 1 month before screening; 8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due to other cancers; 9. There are other circumstances that the researcher thinks are not suitable for participating in this study;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06151119
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The First Affiliated Hospital of Xiamen University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bing Xu
Principal Investigator Affiliation	The First Aiffiliated hosptical of xiamen University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Myelofibrosis

Additional Details

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.

Arms & Interventions

Arms

: suspected or confirmed myelofibrosis

Patients with suspected or confirmed myelofibrosis;

: primary/secondary myelofibrosis

Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.

Interventions

Diagnostic Test: - 68Ga FAPI PET/CT

68Ga FAPI PET/CT

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bing Xu, Xiamen, Fujian, China

Status

Recruiting

Address

Bing Xu

Xiamen, Fujian, 361000

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