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Trial Title:
18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
NCT ID:
NCT06557590
Condition:
Cancer
FAP
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-FAPI-04
Description:
18F-FAPI-04 was injected into the patients before the PET/CT or PET/MR scans
Summary:
To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed
tomography (PET/CT) and positron emission tomography/magnetic resonance imaging
（PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or
assessment of pathologic response in various types of cancer.
Detailed description:
Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging
either for an initial assessment, recurrence detection or assessment of pathologic
response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and
tumor to background (TBR). Using histopathology and follow-up as gold standard, the
sensitivity, specificity, positive predictive value (PPV), negative predictive value
(NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.
Criteria for eligibility:
Study pop:
patients with suspected or new diagnosed or previously treated malignant tumors.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
patients with suspected or new diagnosed or previously treated malignant tumors
(supporting evidence may include MRI, CT, tumor markers and pathology report); patients
who were able to provide informed consent (signed by participant, parent or legal
representative) and assent according to the guidelines of the Clinical Research Ethics
Committee.
Exclusion Criteria:
patients with non-malignant lesions; patients with pregnancy; the inability or
unwillingness of the research participant, parent or legal representative to provide
written informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hunan Cancer hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Ye, PhD
Phone:
86-13755117105
Email:
yehui@hnca.org.cn
Start date:
January 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Source:
Hunan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06557590
