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

NCT06790082 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Helle Zacho, MD, DMSc · Clinical Professor dept. of Nuclear Medicine, Aalborg University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2027-04-30
Completion
2037-04-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06790082 on ClinicalTrials.gov