(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Biopsy proven NSCLC needing 18F-FDG PET/CT for diagnostic workup or biopsy proven NSCLC with 18F-FDG PET/CT already performed"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- ECOG score 0-2"}
• {"criterion_text":"- Possibility to perform 68Ga-FAPI-46 PET with low dose CT within three weeks after 18F-FDG PET/CT"}
• {"criterion_text":"- Willing and able to undergo brain MRI if not already performed or scheduled in regular care"}
• {"criterion_text":"- Provision of signed and dated, written informed consent"}

Exclusion criteria

• {"criterion_text":"- History of lung cancer (treatment) or lung surgery"}
• {"criterion_text":"- History of other malignancies 5 years prior to the current diagnosis of NSCLC (except carcinoma in situ, melanoma in situ)"}
• {"criterion_text":"- Chronic inflammatory disease such as rheumatoid arthritis or fibrotic pulmonary conditions"}
• {"criterion_text":"- Known allergy to MRI contrast agent (i.e gadolinium-based contrast agents) or CT contrast agent (iodinated contrast)"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pregnant and lactating women"}
• {"criterion_text":"- Brain tumor (including meningioma)"}
• {"criterion_text":"- Contra-indication for MRI such as claustrophobia, pacemaker, clips, severe obesity"}

Primary endpoints

• {"endpoint_text":"- Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study","definition_or_measurement_approach":"Determine and report input parameters required for a sample size calculation for a subsequent prospective diagnostic accuracy study (parameters derived from pilot study results)."}
• {"endpoint_text":"- Number and location of metastatic lesions that are detected on the 68Ga-FAPI-46 PET (measure of interest) but not on the 18F-FDG PET in combination with brain MRI (current standard of care)","definition_or_measurement_approach":"Count and record number and anatomical location of metastatic lesions detected by 68Ga-FAPI-46 PET but not detected by 18F-FDG PET/CT plus brain MRI; lesion-level comparison between imaging modalities."}
• {"endpoint_text":"- Number and location of metastatic lesions detected on the 18F FDG PET in combination with brain MRI (current standard of care) but not on 68Ga-FAPI-46 PET (measure of interest)","definition_or_measurement_approach":"Count and record number and anatomical location of metastatic lesions detected by 18F-FDG PET/CT plus brain MRI but not detected by 68Ga-FAPI-46 PET; lesion-level comparison between imaging modalities."}

Secondary endpoints

• {"endpoint_text":"- Number of patients with brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)","definition_or_measurement_approach":"Patient-level comparison: presence/absence of brain metastases on brain MRI and on 68Ga-FAPI-46 PET."}
• {"endpoint_text":"- In patients with brain metastases: number of brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)","definition_or_measurement_approach":"For patients with brain metastases, compare counts of brain metastases detected by brain MRI versus 68Ga-FAPI-46 PET."}
• {"endpoint_text":"- Number of patients with at least one 68Ga-FAPI-positive, 18F-FDG-negative lesion for which an additional investigation is clinically necessary","definition_or_measurement_approach":"Count patients who have ≥1 lesion positive on 68Ga-FAPI and negative on 18F-FDG that leads to a clinically necessary additional investigation (imaging or biopsy)."}
• {"endpoint_text":"- Number of patients whose disease stage is upstaged based on 68Ga-FAPI-46 PET/CT findings compared to staging based on 18F-FDG PET/CT and brain MRI","definition_or_measurement_approach":"Compare clinical stage based on 68Ga-FAPI-46 PET/CT versus standard staging (18F-FDG PET/CT + brain MRI) and count patients with upstaging."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-01-2026

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

8

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Academisch Ziekenhuis Maastricht

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands