Diagnostic utility and accuracy of 68Gallium FAPI PET/CT in patients with TESTicular germ cell tumors – the prospective phase Ib FAPI-TEST study

Diagnostic utility and accuracy of 68Gallium FAPI PET/CT in patients with TESTicular germ cell tumors – the prospective phase Ib FAPI-TEST study - FAPI-Test Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040151

Enrollment

Registered

2026-05-05

Start date

2025-07-17

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C62

Interventions

Group 1: Patients with germ cell tumors in the metastatic stage, with residual disease after chemotherapy, or with localized disease but high-risk factors, receive a 68Ga-FAPI PET-CT after being infor

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: seminoma and non seminoma patients: Clinical Stage: I (high risk and unfavourable histology), IIA, IIB, residual mass after chemotherapy

Exclusion criteria

Exclusion criteria: non willingness to enter the study age < 18

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the diagnostic value of 68Ga-FAPI PET-CT in metastatic germ cell tumors, assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the FAPI PET-CT examination. Results will be compared to conventional imaging as standard of care, or if available histopathology.	—

Countries

Germany

Contacts

Public ContactMaximilian Brandt

Klinik für Urologie und Kinderurologie, Universitätsmedizin Mainz

maximilian.brandt@unimedizin-mainz.de06131 17 2312

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026