Clinical trial NCT04571086: FAPI-PET for Tumor Detection
Official title: 68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm
Keywords: FAPI
cancer
Positron-Emission-Tomography
FAP
fibroblast
imaging
PET
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for FAPI-PET for tumor staging or restaging

Brief summary: This is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.

Detailed description: 68-Ga-fibroblast-activation-protein-inhibitors (68-Ga-FAPI) are novel Positron emission tomography (PET) tracers that were recently introduced for the imaging of patients with various cancer diseases. The fibroblast-activation-protein (FAP) is highly expressed in carcinoma-associated fibroblasts (CAFs) in the stroma of various tumor entities. The aim of this registry study is to collect data on FAPI expression, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI on patients receiving this imaging modality at initial diagnosis or restaging as part of clinical care.

Eligibility criteria: Inclusion Criteria:

1. FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
2. Age ≥ 18 years.

Exclusion Criteria:

1. Patient cannot give consent for the study
2. Patient can not lie flat or tolerate FAPI PET imaging
3. Unwillingness or inability to comply with study and follow-up procedures
4. Condition of patient which is critical to participate in this study in the discretion of the investigators
5. Pregnant, lactating, or breast feeding women.

Primary outcomes:
measure: Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.
timeFrame: 3 Months
Secondary outcomes:
measure: Detection rate on a per-patient-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
timeFrame: 3 Months
measure: Detection rate on a per-region-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
timeFrame: 3 Months
measure: Positive predictive value (PPV) on a per-patient-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
timeFrame: 3 Months
measure: Positive predictive value (PPV) on a per-region-basis of FAPI-PET for detection of tumor location, confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
timeFrame: 3 Months
measure: Sensitivity and specificity of FAPI PET on a per-patient and per-region-basis for detection of tumor location confirmed by histopathology/biopsy (separate for regional, extra-regional and distant locations)
timeFrame: 3 Months
measure: Impact on patient management assessed by pre- and post-imaging questionnaires
timeFrame: 12 Months
measure: Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity
timeFrame: 12 Months
measure: Rate of up- or downstaging following FAPI-PET imaging.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Nuclear medicine, University hospital Essen
state: NRW
Study officials:
affiliation: University Hospital, Essen
name: Wolfgang Fendler, MD
role: PRINCIPAL_INVESTIGATOR
References: