Improved baseline staging with 68Ga-FAPI-46 PET in non-small cell lung cancer – a pilot study
Key facts
- Where
- Maastricht, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Maastricht University Medical CenterMaastricht, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Ziekenhuis Maastricht
- Trial code
- EU 2025-523032-39-00
- Record updated
- 2026. február 3.
- Original description
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a subsequent diagnostic study that compares the diagnostic accuracy of standard 18F-FDG and brain MRI versus 68Ga -FAPI as PET tracer in patients with newly diagnosed NSCLC.Read full original descriptionShow less
The aim of this pilot study is to determine essential input parameters for an adequate sample size calculation for a subsequent diagnostic study that compares the diagnostic accuracy of standard 18F-FDG and brain MRI versus 68Ga -FAPI as PET tracer in patients with newly diagnosed NSCLC.
Inclusion: Biopsy proven NSCLC needing 18F-FDG PET/CT for diagnostic workup or biopsy proven NSCLC with 18F-FDG PET/CT already performed; Age ≥ 18; ECOG score 0-2; Possibility to perform 68Ga-FAPI-46 PET with low dose CT within three weeks after 18F-FDG PET/CT; Willing and able to undergo brain MRI if not already performed or scheduled in regular care; Provision of signed and dated, written informed consent.
Exclusion: History of lung cancer (treatment) or lung surgery; History of other malignancies 5 years prior to the current diagnosis of NSCLC (except carcinoma in situ, melanoma in situ); Chronic inflammatory disease such as rheumatoid arthritis or fibrotic pulmonary conditions; Known allergy to MRI contrast agent (i.e gadolinium-based contrast agents) or CT contrast agent (iodinated contrast); Patients with severe renal impairment (eGFR≤30mL/min/1.73m²; the nuclear tracer is primarily excreted through the kidneys. If a patient has severe renal impairment, clearance is reduced, leading to prolonged circulation of the nuclear tracer in the body); Pregnant and lactating women; Brain tumor (including meningioma); Contra-indication for MRI such as claustrophobia, pacemaker, clips, severe obesity.