FAPI-PET for Tumor Detection
ConditionMalignant Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
Age ≥ 18 years.
Disqualifiers
Patient cannot give consent for the study
Patient can not lie flat or tolerate FAPI PET imaging
Unwillingness or inability to comply with study and follow-up procedures
Condition of patient which is critical to participate in this study in the discretion of the investigators
Trial population
Patients scheduled for FAPI-PET for tumor staging or restaging
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.
Time frame
3 MonthsSecondary outcomes
1
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.
Time frame
3 Months2
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.
Time frame
3 Months3
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.
Time frame
3 Months4
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.
Time frame
3 MonthsSponsors and contacts
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Source ClinicalTrials.gov