FAPI PET/CT Prospective Interobserver Agreement

NCT ID: NCT04990882

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-10-30

Brief 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.

Detailed 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.

Conditions

Malignant Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low Experience Group

Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of less than 30 studies.

Interpretation of FAPI-PET/CT scans

Intervention Type: OTHER

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

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.

Interpretation of FAPI-PET/CT scans

Intervention Type: OTHER

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

High Experience Group

Nuclear medicine physicians or radiologists with a prior experience with 68Ga-FAPI PET/CT of more than 300 studies.

Interpretation of FAPI-PET/CT scans

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. med. Wolfgang Fendler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Fendler, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Department of Nuclear Medicine

Essen, , Germany

Countries

Germany

Other Identifiers

AGREE-FAPI

Identifier Type: -

Identifier Source: org_study_id