FAPI-PET for Tumor Detection

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

Study Overview

• Status: Recruiting
• Conditions: Malignant Neoplasm

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Lukas Kessler, MD; Phone Number: +49 201 723 1862; Email: lukas.Kessler@uk-essen.de
• Study Contact Backup: Name: Wolfgang Fendler, MD; Phone Number: +49 201 723 1862; Email: wolfgang.fendler@uk-essen.de

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45147
      • Recruiting
      • Department of Nuclear medicine, University hospital Essen
      • Contact: Lukas Kessler, MD; Phone Number: +49 201 723 1862; Email: lukas.Kessler@uk-essen.de
      • Sub-Investigator: Jens Siveke, MD
      • Sub-Investigator: Lukas Kessler, MD
      • Contact: Wolfgang Fendler, MD; Phone Number: +49 201 723 1862; Email: wolfgang.fendler@uk-essen.de
      • Principal Investigator: Wolfgang Fendler, MD
      • Sub-Investigator: Nader Hirmas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for FAPI-PET for tumor staging or restaging

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.	3 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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
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
Impact on patient management assessed by pre- and post-imaging questionnaires	12 Months
Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity	12 Months
Rate of up- or downstaging following FAPI-PET imaging.	12 Months

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Investigators: Principal Investigator: Wolfgang Fendler, MD, University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2020
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: imaging; cancer; PET; FAP; FAPI; Positron-Emission-Tomography; fibroblast
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: FAPI PET REG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No