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JOURNAL ONKOLOGIE – STUDIE

FAPI-PET for Tumor Detection

Rekrutierend

NCT-Nummer:
NCT04571086

Studienbeginn:
April 2020

Letztes Update:
30.09.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital, Essen

Collaborator:
-

Studienleiter

Wolfgang Fendler, MD
Principal Investigator
University Hospital, Essen

Kontakt

Studienlocations
(1 von 1)

Department of Nuclear medicine, University hospital Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Wolfgang Fendler, MD
Phone: +49 201 723 1862
E-Mail: wolfgang.fendler@uk-essen.de

Lukas Kessler, MD
Phone: +49 201 723 1862
E-Mail: lukas.Kessler@uk-essen.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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 Months)



Secondary outcome:

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 Months)

2. 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 Months)

3. 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 Months)

4. 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 Months)

5. 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) (Time Frame - 3 Months)

6. Impact on patient management assessed by pre- and post-imaging questionnaires (Time Frame - 12 Months)

7. Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity (Time Frame - 12 Months)

8. Rate of up- or downstaging following FAPI-PET imaging. (Time Frame - 12 Months)

Quelle: ClinicalTrials.gov


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