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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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;

Study details
    Primary Myelofibrosis

NCT06151119

The First Affiliated Hospital of Xiamen University

26 January 2024

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