68Ga-FAPI-46 PET for imaging of gastrointestinal cancers: A prospective interventional single-arm clinical trial (FAPI-PET-GI)

Conditions

cholangiocarcinoma, colorectal cancer and oesophageal cancer), gastric cancers, Gastrointestinal cancers (including hepatocellular carcinoma, pancreatic cancer

Brief summary

Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of gastrointestinal cancers, confirmed by histopathology/ biopsy (reached for ≥ 75%)

Detailed description

Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of gastrointestinal cancers confirmed by histopathology/ biopsy (separate for regional, extra-regional and distant locations), Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region basis for detection of tumour location, also stratified by tumour marker serum level, Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumour lesions confirmed by combined histopathology/ biopsy/ follow-up imaging/ clinical follow-up reference standard (separate for regional, extra-regional and distant locations, Inter-reader reproducibility, Impact on therapy management will be evaluated by pre- & post-imaging questionnaires sent to the treating physicians, Change in staging/ prognostic groups, Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP expression, Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) including vital signs and changes in laboratory parameters

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Positive predictive value (PPV) on a per-region- and per-patient-basis of 68Ga-FAPI-46 PET for detection of gastrointestinal cancers, confirmed by histopathology/ biopsy (reached for ≥ 75%)	—

Secondary

Measure	Time frame
Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of gastrointestinal cancers confirmed by histopathology/ biopsy (separate for regional, extra-regional and distant locations), Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region basis for detection of tumour location, also stratified by tumour marker serum level, Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumour lesions confirmed by combined histopathology/ biopsy/ follow-up imaging/ clinical follow-up reference standard (separate for regional, extra-regional and distant locations, Inter-reader reproducibility, Impact on therapy management will be evaluated by pre- & post-imaging questionnaires sent to the treating physicians, Change in staging/ prognostic groups, Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP express	—

Measure

Time frame

Sensitivity and specificity of 68Ga-FAPI-46 PET on a per-patient and per-region-basis for detection of gastrointestinal cancers confirmed by histopathology/ biopsy (separate for regional, extra-regional and distant locations), Detection rate of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region basis for detection of tumour location, also stratified by tumour marker serum level, Sensitivity and specificity of 68Ga-FAPI-46 PET versus previous standard imaging on a per-patient and per-region-basis for detection of tumour lesions confirmed by combined histopathology/ biopsy/ follow-up imaging/ clinical follow-up reference standard (separate for regional, extra-regional and distant locations, Inter-reader reproducibility, Impact on therapy management will be evaluated by pre- & post-imaging questionnaires sent to the treating physicians, Change in staging/ prognostic groups, Association between 68Ga-FAPI-46 PET uptake intensity and histopathologic FAP express

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Countries

Germany

Outcome results