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AzTrials

Malignant NeoplasmNCT04571086

FAPI-PET for Tumor Detection

An observational study of Malignant Neoplasm, run by University Hospital, Essen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasm
How many people
500 participants
Where
1 siteGermany
Study dates
30 Apr 2020to 30 Apr 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients scheduled for FAPI-PET for tumor staging or restaging

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wolfgang Fendler, MD contact

+49 201 723 1862

wolfgang.fendler@uk-essen.de

Lukas Kessler, MD contact

+49 201 723 1862

lukas.kessler@uk-essen.de

Germany1 site, 1 recruiting

  • Department of Nuclear medicine, University hospital Essen

    Essen, North Rhine-Westphalia, 45147

    Wolfgang Fendler, MD, +49 201 723 1862, wolfgang.fendler@uk-essen.de

    Lukas Kessler, MD, +49 201 723 1862, lukas.Kessler@uk-essen.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
FAPI, cancer, Positron-Emission-Tomography, FAP, fibroblast, imaging, PET
Medical subject headings
Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between 68Ga-FAPI PET uptake intensity and histopathologic FAP expression. Validation via immunohistochemical FAP staining/molecular analyses of pathological specimen.

    Measured: 3 Months

Secondary outcomes (8)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: 3 Months

  6. Impact on patient management assessed by pre- and post-imaging questionnaires

    Measured: 12 Months

  7. Detection rates on a per-patient basis of FAPI-PET stratified by tumor maker serum level and velocity

    Measured: 12 Months

  8. Rate of up- or downstaging following FAPI-PET imaging.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2020
  2. Study start30 Apr 2020
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04571086
Sponsor's protocol ID
FAPI PET REG
Status last verified
Nov 2023
First submitted
15 Sep 2020
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuper AT, Vaz SC, Pabst KM, Ciuciulkaite I, Mavroeidi IA, Hamacher R, Welt A, Hammersen N, Costa PF, Djaileb L, Seifert R, Umutlu L, Schuler M, Herrmann K, Fendler WP, Kummel S, Kersting D. Comparison between [68Ga]Ga-FAPI-46 and [18F]FDG PET/CT uptake in luminal-like vs. HER2-positive breast cancer. EJNMMI Res. 2026 Mar 13;16(1):58. doi: 10.1186/s13550-026-01390-3.

    PubMed 41824221

  • Kessler L, Schwaning F, Metzenmacher M, Pabst KM, Opitz M, Wiesweg M, Aigner C, Ploenes T, Bolukbas S, Doerr F, Stuschke M, Umutlu L, Nader M, Theegarten D, Eberhardt WE, Schuler M, Herrmann K, Fendler WP, Kersting D, Hautzel H. Prognostic Value of Fibroblast Activation Protein-Directed PET Imaging in Pleural Mesothelioma. J Nucl Med. 2026 Mar 2;67(3):383-390. doi: 10.2967/jnumed.125.270906.

    PubMed 41506801

  • Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Kersting D, Siveke JT, Herrmann K, Weber M. Head-to-head comparison of 68 Ga-FAPI-46 PET/CT, 18F-FDG PET/CT, and contrast-enhanced CT for the detection of various tumors. Ann Nucl Med. 2025 Mar;39(3):255-265. doi: 10.1007/s12149-024-01993-7. Epub 2024 Oct 23.

    PubMed 39443386

  • Kessler L, Schwaning F, Metzenmacher M, Pabst K, Siveke J, Trajkovic-Arsic M, Schaarschmidt B, Wiesweg M, Aigner C, Plones T, Darwiche K, Bolukbas S, Stuschke M, Umutlu L, Nader M, Theegarten D, Hamacher R, Eberhardt WEE, Schuler M, Herrmann K, Fendler WP, Hautzel H. Fibroblast Activation Protein-Directed Imaging Outperforms 18F-FDG PET/CT in Malignant Mesothelioma: A Prospective, Single-Center, Observational Trial. J Nucl Med. 2024 Aug 1;65(8):1188-1193. doi: 10.2967/jnumed.124.267473.

    PubMed 38960716

  • Oster C, Kessler L, Blau T, Keyvani K, Pabst KM, Fendler WP, Fragoso Costa P, Lazaridis L, Schmidt T, Feldheim J, Pierscianek D, Schildhaus HU, Sure U, Ahmadipour Y, Kleinschnitz C, Guberina N, Stuschke M, Deuschl C, Scheffler B, Herrmann K, Kebir S, Glas M. The Role of Fibroblast Activation Protein in Glioblastoma and Gliosarcoma: A Comparison of Tissue, 68Ga-FAPI-46 PET Data, and Survival Data. J Nucl Med. 2024 Aug 1;65(8):1217-1223. doi: 10.2967/jnumed.123.267151.

    PubMed 38960714

  • Watanabe M, Fendler WP, Grafe H, Hirmas N, Hamacher R, Lanzafame H, Pabst KM, Hautzel H, Aigner C, Kasper S, von Tresckow B, Stuschke M, Kummel S, Lugnier C, Hadaschik B, Grunwald V, Zarrad F, Siveke JT, Herrmann K, Weber M. Prognostic Implications of 68Ga-FAPI-46 PET/CT-Derived Parameters on Overall Survival in Various Types of Solid Tumors. J Nucl Med. 2024 Jul 1;65(7):1027-1034. doi: 10.2967/jnumed.123.266981.

    PubMed 38782454

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Neoplasm, run by University Hospital, Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wolfgang Fendler, MD (+49 201 723 1862, wolfgang.fendler@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04571086, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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