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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-22

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Myelofibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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suspected or confirmed myelofibrosis

Patients with suspected or confirmed myelofibrosis;

68Ga FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

68Ga FAPI PET/CT

primary/secondary myelofibrosis

Patients with primary/secondary myelofibrosis who were not treated with ruxolitinib.

68Ga FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

68Ga FAPI PET/CT

Interventions

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68Ga FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No