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

Sponsor
The First Affiliated Hospital of Xiamen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06151119
Collaborator
(none)
90
Enrollment
1
Location
19.3
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 68Ga FAPI PET/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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Study to Evaluate 68Ga-FAPI PET/CT Imaging for Diagnosis, Grading, and Efficacy Evaluation of Myelofibrosis.
Actual Study Start Date :
Nov 22, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Cohort 1

Patients with suspected or confirmed myelofibrosis;

Diagnostic Test: 68Ga FAPI PET/CT
use 68Ga FAPI PET/CT to diagnose myelofibrosis
Cohort 2

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

Diagnostic Test: 68Ga FAPI PET/CT
use 68Ga FAPI PET/CT to diagnose myelofibrosis

Outcome Measures

Primary Outcome Measures

  1. Sensitivity [Up to 24 months]

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

  2. Specificity [Up to 24 months]

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

  3. Positive prediction rate [Up to 24 months]

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

  4. Negative prediction rate [Up to 24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bing Xu Xiamen Fujian China 361000

Sponsors and Collaborators

  • The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Bing Xu, The First Aiffiliated hosptical of xiamen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bing, Xu, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier:
NCT06151119
Other Study ID Numbers:
  • XMDYYYXYK-06
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bing, Xu, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Xiamen University
Myelofibrosis
positron emission tomography / computed tomography
Additional relevant MeSH terms:
Primary Myelofibrosis

Study Results

No Results Posted as of Nov 30, 2023