The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma

NCT06790082 | Recruiting Phase 2 DMC

• 2 other identifiers: EU CT: 2024-514301-62-002024-514301-62-00
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET/CT at primary staging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT). The diagnostic accuracy will be determined with histopathology as reference standard. For patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET/CT and an additional FDG PET/CT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET/CT in response evaluation will be investigated. All study specific analyzes will be blinded and will not influence the patient management / treatment.

Conditions

Pleural Mesothelioma; Pleural Diseases; Cancer; FAPI; Fibroblast Activation Protein Inhibitor

Keywords

FAPI; 68Ga-FAPI-46; PET/CT; Pleural Mesothelioma; FDG PET/CT

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

  The diagnostic performance (sensitivity, specificity, positive predicative value, negative predicative value, and overall diagnostic accuracy - all parameters in %). in of FAPI PET compared to routine imaging modalities, including FDG PET/CT, in suspected PM lesions.

  2 years

Secondary Outcomes (12)

• Location biopsy

  2 years

• Staging

  2 years

• Patient Management

  2 years

• Uptake Values

  2.5 years

• Changes uptake parameters due to anticancer treatment

  2.5 years

Study Arms (1)

Suspected pleural mesothelioma

EXPERIMENTAL

Patients with suspected pleural mesotheliom undergo an additional study specific \[68Ga\]Ga-FAPI-46 PET/CT at primary staging.

Drug: [68Ga]Ga-FAPI-46 PET/CT

Interventions

[68Ga]Ga-FAPI-46 PET/CT DRUG

Patients with suspected pleural mesothelioma undergo FAPI PET/CT in addition to conventional imaging at primary staging. The subgroup of patients undergoing anticancer treatment will undergo an additional FAPI PET/CT and FDG PET/CT after completing 2-3 series of anticancer treatment.

Also known as: [68Ga]Gallium - Fibroblast Activation Protein Inhibitor-46 Positron Emission Tomography / Computer Tomography

Suspected pleural mesothelioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy.
• Undergone/undergoing FDG PET/CT as part of the diagnostic workup of a suspicious PM lesion.
• Considered physically and mentally able to participate in the research project.
• Understands the study subject information and able to consent to project participation.
• years or older

You may not qualify if:

• Patients with an imminent need for surgery or in an emergency
• Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt.
• Pregnant or breastfeeding women.
• Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status).
• Fertile women will be tested for pregnancy (by urine humane choriogonadotropin (HCG) or serum HCG) within 48h before FAPI PET/CTs, both at primary staging and restaging. Study subjects can participate in the study if the pregnancy test is negative (i.e., not pregnant).
• Subjects unable to undergo PET/CT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain still for the duration of the examination, or with known severe claustrophobia unresponsive to oral anxiolytics or severe fear of needles.
• Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
• History of allergic reactions / hypersensitivity attributed to \[18F\]FDG or FAPI-tracers.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Region North Jutland, 9000, Denmark

RECRUITING

Related Publications (3)

• Guglielmo P, Crivellaro C, Castello A, Della Corte CM, Pagano M, Marchesi S, Occhipinti M, Zucali PA, Evangelista L. Emerging Radiopharmaceuticals in Pet Imaging for Mesothelioma: A Review of [18F]FDG Alternatives. Mol Diagn Ther. 2025 Jan;29(1):55-66. doi: 10.1007/s40291-024-00756-4. Epub 2024 Nov 8.

  PMID: 39514167 BACKGROUND

• Guzel Y, Komek H, Can C, Kaplan I, Kepenek F, Ebinc S, Buyukdeniz MP, Gundogan C, Oruc Z. Comparison of the role of 18 F-fluorodeoxyglucose PET/computed tomography and 68 Ga-labeled FAP inhibitor-04 PET/CT in patients with malignant mesothelioma. Nucl Med Commun. 2023 Jul 1;44(7):631-639. doi: 10.1097/MNM.0000000000001702. Epub 2023 Apr 28.

  PMID: 37114422 BACKGROUND

• Kessler L, Schwaning F, Metzenmacher M, Pabst K, Siveke J, Trajkovic-Arsic M, Schaarschmidt B, Wiesweg M, Aigner C, Plones T, Darwiche K, Bolukbas S, Stuschke M, Umutlu L, Nader M, Theegarten D, Hamacher R, Eberhardt WEE, Schuler M, Herrmann K, Fendler WP, Hautzel H. Fibroblast Activation Protein-Directed Imaging Outperforms 18F-FDG PET/CT in Malignant Mesothelioma: A Prospective, Single-Center, Observational Trial. J Nucl Med. 2024 Aug 1;65(8):1188-1193. doi: 10.2967/jnumed.124.267473.

  PMID: 38960716 BACKGROUND

MeSH Terms

Conditions

Mesothelioma, Malignant; Pleural Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helle Zacho, MD, DMSc

  Clinical Professor dept. of Nuclear Medicine, Aalborg University Hospital

  STUDY DIRECTOR

Central Study Contacts

Morten Bentestuen, MD

CONTACT

+45 97665500; m.bentestuen@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 23, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2037
• Last Updated: July 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)