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A study to evaluate 68Ga-FAPI PET/CT imaging for diagnosis, grading and efficacy evaluation of myelofibrosis.

A clinical study to evaluate 68Ga-FAPI PET/CT imaging for diagnosis, grading and efficacy evaluation of myelofibrosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300078406
Enrollment
Unknown
Registered
2023-12-07
Start date
2023-12-10
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelofibrosis

Interventions

Gold Standard:bone marrow biopsy
Index test:FAPI-PET/CT

Sponsors

The First Aiffiliated hosptical of xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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 greater than 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

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;

Design outcomes

Primary

MeasureTime frame
sensitivity;Specificity;Positive prediction rate;Negative prediction rate;

Countries

China

Contacts

Public ContactBing Xu

The First Aiffiliated hosptical of xiamen University

xubingzhangjain@126.com+86 187 5091 8842

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026