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

Brief Summary

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

Tracking Information
First Received DateApril 19, 2016
Last Changed DateNovember 18, 2016
Start DateApril 2016
Anticipated Primary Completion DateApril 2023
Primary Outcome Measures

Study Ia: Overall survival (OS) [Time Frame: Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease)]

Study Ib: Overall survival (OS) [Time Frame: Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease)]

Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-) [Time Frame: Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105]

Secondary Outcome Measures

Study Ia: Progression free survival (PFS) [Time Frame: Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease)]

Study Ib: Disease free survival (DFS) [Time Frame: Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease)]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Non-small Cell Lung Cancer
  • Malignant Pleural Mesothelioma
  • Large Cell Neuroendocrine Carcinoma of the Lung
Intervention
  • Other: 68Ga-NOTA-AE105 PET/CT
Study Arms / Comparison Groups1 / 0
Detailed 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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment120
GenderAll
Ages18 Years - 85 Years
Accepts Healthy VolunteersNo
Contact Malene M Clausen, MD, PhD
Email: malene.martini.clausen@regionh.dk
Phone: +4522524536
Eligibility Criteria

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

Administrative Information
NCTIDNCT02755675
Responsible Party,
SponsorRigshospitalet, Denmark
Verification DateNovember 2016
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