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

Last updated: February 18, 2025
Sponsor: The First Affiliated Hospital of Xiamen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-polycythemia Vera Myelofibrosis

Myelofibrosis

Treatment

68Ga FAPI PET/CT

Clinical Study ID

NCT06151119
XMDYYYXYK-06
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old;

  2. Cohort 1: Patients with suspected or confirmed myelofibrosis; Cohort 2: Patientswith 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

Exclusion Criteria:

  1. Known allergic history to 68Ga FAPI or its excipients;

  2. Patients who can not tolerate intravenous drug administration (such as needlefainting and blood fainting history);

  3. Those who are not suitable for or unable to complete imaging tests such as PET dueto 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, mentalsystem, immune deficiency diseases and hepatitis/cirrhosis;

  7. Participating in other interventional clinical trials within 1 month beforescreening;

  8. Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy due toother cancers;

  9. There are other circumstances that the researcher thinks are not suitable forparticipating in this study;

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: 68Ga FAPI PET/CT
Phase:
Study Start date:
November 22, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Bing Xu

    Xiamen, Fujian 361000
    China

    Active - Recruiting

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