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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Chinese people

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 68Ga FAPI PET/CT

    Diagnostic test

    68Ga FAPI PET/CT

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: suspected or confirmed myelofibrosis1 intervention
Group B: primary/secondary myelofibrosis1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

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

Time frame
Up to 24 months
2

Specificity

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

Time frame
Up to 24 months
3

Positive prediction rate

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

Time frame
Up to 24 months
4

Negative prediction rate

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

Time frame
Up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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