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FAPI-PET for Tumor Detection

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ClinicalTrials.gov Identifier: NCT04571086
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Wolfgang Fendler, University Hospital, Essen

Brief 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: 68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2026



Primary Outcome Measures :
  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 Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood samples, tissue samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for FAPI-PET for tumor staging or restaging
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571086


Contacts
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Contact: Wolfgang Fendler, MD +49 201 723 1862 wolfgang.fendler@uk-essen.de
Contact: Lukas Kessler, MD +49 201 723 1862 lukas.kessler@uk-essen.de

Locations
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Germany
Department of Nuclear medicine, University hospital Essen Recruiting
Essen, NRW, Germany, 45147
Contact: Wolfgang Fendler, MD    +49 201 723 1862    wolfgang.fendler@uk-essen.de   
Contact: Lukas Kessler, MD    +49 201 723 1862    lukas.Kessler@uk-essen.de   
Principal Investigator: Wolfgang Fendler, MD         
Sub-Investigator: Jens Siveke, MD         
Sub-Investigator: Nader Hirmas, MD         
Sub-Investigator: Lukas Kessler, MD         
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Wolfgang Fendler, MD University Hospital, Essen
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Responsible Party: PD Dr. med. Wolfgang Fendler, MD, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT04571086    
Other Study ID Numbers: FAPI PET REG
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PD Dr. med. Wolfgang Fendler, University Hospital, Essen:
FAPI
cancer
Positron-Emission-Tomography
FAP
fibroblast
imaging
PET
Additional relevant MeSH terms:
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Neoplasms