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Completed

NCT Number: NCT04990882

FAPI PET/CT Prospective Interobserver Agreement

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine

Essen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Agreement among observer groups in interpreting FAPI PET/CT scans

    Time frame: 3 Months

    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).

Secondary outcomes

  1. Agreement among observer groups in interpreting TNM stage and semi-quantitative values.

    Time frame: 3 Months

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study

Acronym: AGREE-FAPI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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