FAPI-PET imaging in solid tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

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]

Trial duration

3 Jul 2024 → ongoing

Decision date (initial)

2025-07-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

The Cancer Research Funds of Radiumhemmet (Radiumhemmets Forskningsfonder) · The Swedish Cancer Society (Cancerfonden) · Region Stockholm (Stockholm County Council) · The Sjöberg Foundation (Sjöbergstiftelsen)

External identifiers

EU CT number

2024-514967-25-00

EudraCT number

2020-002568-30

ClinicalTrials.gov

NCT05172310

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To improve non-invasive diagnostics of malignancy in tumors of pancreas, stomach, and bile ducts, as well as in epithelial ovarian cancer (EOC)

Secondary objectives 5

1. To evaluate FAPI- PET/CT as a staging tool for pancreatic-, gastric- and bile duct cancers as well as for primary and recurrent EOC
2. To investigate the correlation between in-vivo uptake of FAPI and ex-vivo immunohistochemically determined biomarker (FAP, PDGFR-α, PDGFR-β and α-SMA) expression in the stroma of these tumors
3. To evaluate FAPI- PET/CT and stroma markers as prognostic factors in patients with these cancer entities
4. To investigate the correlation between FAPI- PET/CT imaging results with those of conventional radiology performed according to clinical routine (SOP), i.e. CT and MRT imaging, as well as gastroscopy including biopsy for the patient group with gastric cancer
5. To evaluate the safety and tolerability of the investigational product

Conditions and MedDRA coding

Cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 1. The subject has given written consent to participate in the study
2. 2. The subject has suspected pancreatic, gastric, biliary or epithelial ovarian cancer based on multimodal strategy including markers in blood, markers in tissue and imaging diagnostics; scheduled for surgical removal of this lesion with histopathological confirmation of diagnosis.

Exclusion criteria 6

1. Age ≤18 year
2. Pregnancy and lactation
3. Known metastatic disease (Not applicable for the EOC study group as most cases are already metastasized at the point of primary diagnosis)
4. Significantly reduced renal function
5. Allergy to iodinated contrast media
6. Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Surgery with histopathological confirmation of diagnosis

Secondary endpoints 5

1. To evaluate FAPI- PET/CT as a staging tool for all included cancer entities, the secondary endpoint variables will be assessed with the histopathological diagnosis as a refence standard for regional or distant lymph nodes and/or resected local or distant metastatic tumor tissue when present.
2. To investigate the correlation between in-vivo uptake of FAPI and ex-vivo immunohistochemically determined biomarker (FAP, PDGFR-α, PDGFR-β and α-SMA) expression in the stroma of these tumors, postsurgical histopathological confirmation of diagnosis will be used for confirmation of tumor histology (benign and malignant).
3. Assessment of FAPI- PET/CT and stroma markers as prognostic factors in patients with these cancers will be performed by recording disease free survival (DFS) and overall survival OS at 1 – year, 2 – years and 5 – years clinical follow – ups continuously during the follow – up period of the study.
4. 4. To investigate the difference in diagnostic accuracy of FAPI- PET/CT compared to conventional radiology performed according to clinical routine, either postsurgical histopathological or histopathological/cytological (in the case of tissue biopsy material) confirmation of diagnosis will be used as a reference standard for differential diagnosis between malignant and benign lesions as well as for N and M staging
5. To investigate the frequency of Adverse Events (AEs), Adverse Reactions (ARs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Halsovagen, Flemingsberg Flemingsberg

City

Huddinge

Postcode

141 86

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Rimma Axelsson

Public contact point

Organisation

Karolinska University Hospital

Contact name

Pawel Rasinski

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 19 files

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

Application history

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