Meeting
2023 ASCO Annual Meeting
68Ga-FAPI-46 PET for cancer imaging: A prospective single-arm clinical trial.
Authors
Wolfgang P. Fendler
Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany
Wolfgang P. Fendler , Timo Bartel , Kim M. Pabst , Rainer Hamacher , Nader Hirmas , Robert Seifert , Stefan Kasper , Michael Nader , Claudia Kesch , Bastian von Tresckow , Christoph Berliner , Sherko Kuemmel , Philipp Harter , Anke C. Reinacher-Schick , Celine Lugnier , Waldemar Uhl , Boris A. Hadaschik , Jens T. Siveke , Viktor Grünwald , Ken Herrmann
Organizations
Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany, Department of Nuclear Medicine, German Cancer Consortium (DKTK) University Hospital Essen, Essen, Germany, Department of Medical Oncology, University Hospital Essen, West German Cancer Center, University Duisburg-Essen, Essen, Germany, Department of Nuclear Medicine, University Hospital Essen, Essen, Germany, Department of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany, Department of Urology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany, Department of Hematology and Stem Cell Transplantation, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany, Breast Unit, Kliniken Essen-Mitte, Essen, Germany, Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany, Department of Hematology, Oncology and Palliative Care, St. Josef-Hospital, Ruhr-University Bochum, Bochum, Germany, Ruhr-University Bochum, St. Josef Hospital, Bochum, Germany, Department of Urology, University Hospital Essen, Essen, Germany, Essen, Germany, University Hospital Essen, West German Cancer Center, Essen, Germany, Essen University Hospital, West German Cancer Center, Clinic for Medical Oncology & Clinic for Urology, Essen, Germany
Research Funding
Pharmaceutical/Biotech Company
SOFIE Bioscience, University Duisburg-Essen
Background: Fibroblast activation protein (FAP) is expressed at high levels on tumor associated fibroblasts. FAP-directed radioligand positron-emission-tomography (FAP-PET) is a novel diagnostic tool for cancer. However, we currently do not understand the diagnostic performance of FAP-PET as compared to standard FDG-PET. Here we aim to compare tumor detection by FDG- vs. FAP-PET with independent validation of discrepant findings. Methods: Patients with (a) proven or suspected malignancy, (b) longest tumor diameter >1 cm, (c) intended surgery or biopsy, and (d) no prior external beam radiation or systemic tumor therapy within 3 months underwent FDG- and FAP-PET for tumor localization on subsequent days. Clinical reads were analyzed prospectively on a per-patient and per-region basis (local, locoregional nodal, distant organ or soft tissue, bone). Discrepant findings were validated as true vs. false positive by histopathology or image follow-up. Tracer uptake in tumor tissue was assessed by SUVmax. Results: In total n=100 patients (median 62 years, male/female n=68/32) underwent FDG- and FAP-PET. Five most frequent tumor entities and respective median FDG vs FAP uptake were RCC (n=19; SUVmax 8.4 vs. 7.1), sarcoma (n=18; 10.3 vs. 10.9), NSCLC (n=10; 12.4 vs. 13.7), lymphoma (n=9; 18.3 vs. 10.9), and PDAC (n=8; 4.1 vs. 7.3). On a per-patient basis, FDG- vs FAP-PET localized malignancy in n=93/94 patients. FDG- vs FAP-PET was concordant for the assessment of 362/400 (91%) regions. n=16/400 (4%) regions were negative on FDG- and positive on FAP-PET (88% true, 12% false positive). n=22/400 (6%) regions were negative on FAP- and positive on FDG-PET (57% true, 43% false positive). Two false positive FDG-PET findings were due to tracer uptake in reactive lymph nodes. There were no PET-related adverse events. Conclusions: In patients with various tumor entities, standard FDG- and novel FAP-PET localized tumor equally well. Additionally, FAP-PET was associated with a lower rate of false positive findings, especially in lymph node assessments. Clinical trial information: NCT05160051.
| Tumor entity (n=100 patients) | n |
|---|---|
| RCC | 19 |
| Sarcoma | 18 |
| NSCLC | 10 |
| Lymphoma | 9 |
| PDAC | 8 |
| Bladder | 7 |
| Breast | 4 |
| Colorectal | 4 |
| Other | 21 |
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Abstract Details
Session Type
Poster Session
Session Title
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Track
Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Sub Track
Molecular Diagnostics and Imaging
Clinical Trial Registration Number
NCT05160051
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 3064)
DOI
10.1200/JCO.2023.41.16_suppl.3064
Abstract #
3064
Poster Bd #
262
Abstract Disclosures
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