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NCT Number: NCT06151119

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • 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;

Treatment and study plan

68Ga FAPI PET/CT

Diagnostic Test

68Ga FAPI PET/CT

Primary outcomes

  1. Sensitivity

    Time frame: Up to 24 months

    Sensitivity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.

  2. Specificity

    Time frame: Up to 24 months

    Specificity of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.

  3. Positive prediction rate

    Time frame: Up to 24 months

    Positive prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.

  4. Negative prediction rate

    Time frame: Up to 24 months

    Negative prediction rate of 68Ga-FAPI PET/CT Imaging for the detection of Myelofibrosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 30, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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