Malignant Neoplasm Clinical Trial
— AGREE-FAPIOfficial title:
FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study
Verified date | November 2022 |
Source | University Hospital, Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.
Status | Completed |
Enrollment | 15 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT from high-volume centers (Essen, Germany; Bologna, Italy; Los Angeles, USA; Munich, Germany, Münster, Germany ) will be prospectively recruited as research observers. Each observer will be asked to report the number of previous clinical 68Ga-FAPI PET/CT scans and then will be classified on the basis of the experience in these three groups: - Low experience (< 30 prior 68Ga-FAPI PET/CT studies); - Intermediate experience (30 to 300 studies); - High experience (> 300 studies) At least three observers will be needed for each group. Exclusion criteria: No prior PET/CT experience. |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Nuclear Medicine | Essen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Essen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement among observer groups in interpreting FAPI PET/CT scans | Number of concordant scans among observer groups. Each scan will be rated as positive, negative or suspicion. For each scan all definite and suspicious lesions will be reported as well. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology). | 3 Months | |
Secondary | Agreement among observer groups in interpreting TNM stage and semi-quantitative values. | Number of concordant scans for TNM staging and for semi-quantitative values among observer groups. For each scan all definite and suspicious lesions with uptake values will be reported and a post-analysis TNM staging will be performed. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology). | 3 Months |
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