Clinical trial NCT04990882: FAPI PET/CT Prospective Interobserver Agreement
Official title: FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Keywords: FAPI
cancer
Positron-Emission-Tomography
FAP
fibroblast
imaging
PET
Interobserver agreement
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

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.

Primary outcomes:
measure: Agreement among observer groups in interpreting FAPI PET/CT scans
timeFrame: 3 Months
Secondary outcomes:
measure: Agreement among observer groups in interpreting TNM stage and semi-quantitative values.
timeFrame: 3 Months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Nuclear Medicine
Study officials:
affiliation: Study Principal Investigator
name: Wolfgang Fendler, MD
role: PRINCIPAL_INVESTIGATOR
References: