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FAPI-PET for Tumor Detection

NCT ID: NCT04571086

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-30

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. med. Wolfgang Fendler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang Fendler, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

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Department of Nuclear medicine, University hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Wolfgang Fendler, MD

Role: CONTACT

[email protected]
+49 201 723 1862

Lukas Kessler, MD

Role: CONTACT

[email protected]
+49 201 723 1862

Facility Contacts

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Wolfgang Fendler, MD

Role: primary

[email protected]
+49 201 723 1862

Lukas Kessler, MD

Role: backup

[email protected]
+49 201 723 1862

References

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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.

Reference Type DERIVED
PMID: 39443386 (View on PubMed)

Other Identifiers

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FAPI PET REG

Identifier Type: -

Identifier Source: org_study_id