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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.
Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions.
Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium.
There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of less than 30 studies. |
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| Intermediate Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 30 studies and less than 300 studies. |
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| High Experience Group | Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 300 studies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interpretation of FAPI-PET/CT scans | Other | Each observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
Exclusion criteria:
No prior PET/CT experience.
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Each recruited observer will be asked to review 50 68Ga-FAPI PET/CT scans of patients with different types of tumor.
Observers will be blinded to clinical data except of the following patient information: sex, age (years), weight (Kg), injected dose (MBq), uptake time (min), type of cancer and PET/CT indication (e.g. staging, re-staging after surgery, evaluation after therapy).
Each observer will be also asked to record maximum standardized uptake value (SUVmax) for one exemplary lesion for each tissue (organ, node, bone).
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Fendler, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear Medicine | Essen | Germany |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 3 Months |