FAPI-PET for Tumor Detection

Malignant Neoplasm Clinical Trial

Official title:

68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571086
• Other study ID #: FAPI PET REG
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

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