2025-523032-39-00Not yet recruitingPhase 2
Improved baseline staging with 68Ga-FAPI-46 PET in non-small cell lung cancer – a pilot study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Oct 2025
- Start date
- 2 Feb 2026
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Diseases
- Lung cancer
- EU CT number
- 2025-523032-39-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed non-small cell lung cancer (NSCLC) proven by biopsy. It compares a new PET scan tracer (68Ga-FAPI-46) with the standard scan.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Biopsy-proven non-small cell lung cancer that needs, or already had, an 18F-FDG PET/CT scan as part of diagnosis
- Earlier treatment
- No earlier lung cancer treatment and no earlier lung surgery
Main reasons for not taking part
- History of lung cancer (treatment) or lung surgery
- Other cancer in the 5 years before the NSCLC diagnosis (except carcinoma in situ, melanoma in situ)
- Chronic inflammatory disease such as rheumatoid arthritis or fibrotic lung conditions
- Severe kidney problems (eGFR ≤30 mL/min/1.73 m²)
- Pregnant or breastfeeding women
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- 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)
Other
- Pregnant and lactating women
- Brain tumor (including meningioma)
- Contra-indication for MRI such as claustrophobia, pacemaker, clips, severe obesity
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.