uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung

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Rigshospitalet

Status and phase

Enrolling
Phase 2

Conditions

Malignant Pleural Mesothelioma
Large Cell Neuroendocrine Carcinoma of the Lung
Non-small Cell Lung Cancer

Treatments

Other: 68Ga-NOTA-AE105 PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT02755675
AK-2015-LC-1

Details and patient eligibility

About

uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Full description

Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR. Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Study I

  • Histologically verified NSCLC (Study I)
  • Stage IV disease
  • Operable disease
  • The participants must be capable of understanding and giving full informed written consent

Study II

  • Histologically verified MPM (Study II)
  • The participants must be capable of understanding and giving full informed written consent

Study III

  • Histologically verified LCNEC (Study III)
  • The participants must be capable of understanding and giving full informed written consent

Exclusion criteria

Study I, II, III

  • Pregnancy
  • Lactation/breast feeding
  • Treatment with neoadjuvant chemotherapy
  • Weight above 140 kg
  • Allergy to 68Ga-NOTA-AE105

Trial design

120 participants in 1 patient group

68Ga-NOTA-AE105 PET/CT
Experimental group
Description:
One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before treatment start to evaluate the prognostic value of uPAR PET/CT.
Treatment:
Other: 68Ga-NOTA-AE105 PET/CT

Trial contacts and locations

1

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Central trial contact

Andreas Kjaer, MD,DMSc,PhD; Malene M Clausen, MD, PhD

Data sourced from clinicaltrials.gov

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