FAPI PET/CT Prospective Interobserver Agreement

Malignant Neoplasm Clinical Trial

— AGREE-FAPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990882
• Other study ID #: AGREE-FAPI
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Interpretation of FAPI-PET/CT scans
Each observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types.

Locations

Country	Name	City	State
Germany	Department of Nuclear Medicine	Essen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

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