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NCT Number: NCT04571086

FAPI-PET for Tumor Detection

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.

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Key information

Conditions

Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear medicine, University hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location status: Recruiting

Location contact

Jens Siveke, MD

SUB_INVESTIGATOR

Lukas Kessler, MD

CONTACT

[email protected]

+49 201 723 1862

Lukas Kessler, MD

SUB_INVESTIGATOR

Nader Hirmas, MD

SUB_INVESTIGATOR

Wolfgang Fendler, MD

CONTACT

[email protected]

+49 201 723 1862

Wolfgang Fendler, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
  • Age ≥ 18 years.

Exclusion criteria

  • 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
  • Pregnant, lactating, or breast feeding women.

Treatment and study plan

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 Months

Secondary 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 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lukas Kessler, MD

CONTACT

[email protected]

+49 201 723 1862

Wolfgang Fendler, MD

CONTACT

[email protected]

+49 201 723 1862

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Sep 30, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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