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Recruiting NCT06151119

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

— Observational Primary Myelofibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga FAPI PET/CT.
Who it may be relevant to
Registry conditions: Primary Myelofibrosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed 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.

Interventions

  • Diagnostic test 68Ga FAPI PET/CT
    68Ga FAPI PET/CT

Primary outcome measures

  • Sensitivity [Time frame: Up to 24 months]
  • Specificity [Time frame: Up to 24 months]
  • Positive prediction rate [Time frame: Up to 24 months]
  • Negative prediction rate [Time frame: Up to 24 months]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Bing Xu — Xiamen

Identifiers

NCT: NCT06151119 · XMDYYYXYK-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗