Improved baseline staging with 68Ga-FAPI-46 PET in non-small cell lung cancer – a pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Academisch Ziekenhuis Maastricht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-02-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis, Others

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.

Secondary objectives 3

1. To determine the correlation between 68Ga-FAPI-46 PET and brain MRI in patients with brain metastases
2. To evaluate the clinical necessity to perform additional investigations (imaging or biopsy) based on 68Ga-FAPI-46 PET
3. To evaluate whether 68Ga-FAPI-46 PET leads to disease upstaging compared to standard imaging with 18F-FDG PET/CT and brain MRI

Conditions and MedDRA coding

Non-small cell lung cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Determining essential input parameters for the calculation of an appropriate sample size for a future prospective diagnostic study
2. 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)
3. 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)

Secondary endpoints 4

1. Number of patients with brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)
2. In patients with brain metastases: number of brain metastases on brain MRI (standard of care) and on 68Ga-FAPI-46 PET (measure of interest)
3. Number of patients with at least one 68Ga-FAPI-positive, 18F-FDG-negative lesion for which an additional investigation is clinically necessary
4. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Academisch Ziekenhuis Maastricht

Sponsor organisation

Academisch Ziekenhuis Maastricht

Address

P Debyelaan 25

City

Maastricht

Postcode

6229 HX

Country

Netherlands

Scientific contact point

Organisation

Academisch Ziekenhuis Maastricht

Contact name

T.J.A van Nijnatten

Public contact point

Organisation

Academisch Ziekenhuis Maastricht

Contact name

T.J.A van Nijnatten

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications