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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04571086
Other study ID # FAPI PET REG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 30, 2020
Est. completion date April 30, 2027

Study information

Verified date November 2023
Source University Hospital, Essen
Contact Wolfgang Fendler, MD
Phone +49 201 723 1862
Email wolfgang.fendler@uk-essen.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 30, 2027
Est. primary completion date April 30, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Nuclear medicine, University hospital Essen Essen NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen. 3 Months
Secondary 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. 3 Months
Secondary 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. 3 Months
Secondary 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. 3 Months
Secondary 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. 3 Months
Secondary 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) 3 Months
Secondary Impact on patient management assessed by pre- and post-imaging questionnaires 12 Months
Secondary Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity 12 Months
Secondary Rate of up- or downstaging following FAPI-PET imaging. 12 Months
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