uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer

Overview

uPAR PET/CT for Staging Advanced and Localised oral and oropharyngeal cancer

Full Title of Study: “Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Detailed Description

To compare the diagnostic value of uPAR-PET/CT for prognostication compared to the current imaging options (CT, MRI and ultrasound) by observer-blinded readings. The reference that will be used as "gold standard" is the pathological examination of the surgically removed tissues. The new imaging modality (uPAR-PET/CT) will be used in two separate groups of patients with head and neck cancer: Study I: Patients with oral cancer without clinical evidence of spread (OSCC in stage cN0) Study II: Patients with metastatic oral cancer (OSCC in stage cN +) and patients with metastatic oropharyngeal cancer (OPSCC in stage cN +).

Interventions

  • Other: 68Ga-NOTA-AE105 PET/CT
    • One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.

Arms, Groups and Cohorts

  • Experimental: 68Ga-NOTA-AE105 PET/CT
    • One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before surgery and compared with the histological findings to evaluate uPAR PET/CT in staging of oral cancer and oropharyngeal cancer.

Clinical Trial Outcome Measures

Primary Measures

  • The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
    • Time Frame: Through study completion, an average of 1.5 year

Secondary Measures

  • Evaluation of the correlation between uPAR PET signal (quantified as SUVmax) and the immunohistochemical expression of uPAR evaluated by an H-score (intensity x the percentage of stained tumor tissues throughout the tumor margin).
    • Time Frame: Through study completion, an average of 1.5 year
  • Evaluation of the correlation between tumor burden (assessed v.h.a. TNM staging) uPAR-PET signal (assessed as SUVmax) and the amount of uPAR metabolites in plasma.
    • Time Frame: Through study completion, an average of 1.5 year
  • Determination of the lower detection limit of the amount of tumor tissue for uPAR-PET correlated with the histological H-score x tumor size (where tumor size is evaluated on the pathological preparation of pathologist)
    • Time Frame: Through study completion, an average of 1.5 year

Participating in This Clinical Trial

Inclusion Criteria

  • Able to understand patient information and to give informed consent – Not previously irradiated or operated on neck – Operable disease Study I OSCC cN0 verified histologically by pathologic examination of biopsy Study II OSCC or OPSCC N + verified histologically by pathologic examination of biopsy Exclusion Criteria:

  • Pregnancy – Patients who are candidates for curative intentional radiation – Patients who have had surgery or radiation therapy to the neck as this may alter the lymph drainage. – Other diseases assessed by the investigator as basis for exclusion. – Age under 18 or over 85 years – Obesity> 140 kg – Allergy to 68Ga-NOTA-AE105

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kirstine Karnov, MD, PhD-student – Rigshospitalet, Denmark
  • Overall Official(s)
    • Andreas Kjær, MD,DMSc,PhD, Study Director, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Citations Reporting on Results

Skovgaard D, Persson M, Brandt-Larsen M, Christensen C, Madsen J, Klausen TL, Holm S, Andersen FL, Loft A, Berthelsen AK, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. Safety, Dosimetry, and Tumor Detection Ability of 68Ga-NOTA-AE105: First-in-Human Study of a Novel Radioligand for uPAR PET Imaging. J Nucl Med. 2017 Mar;58(3):379-386. doi: 10.2967/jnumed.116.178970. Epub 2016 Sep 8.

Persson M, Skovgaard D, Brandt-Larsen M, Christensen C, Madsen J, Nielsen CH, Thurison T, Klausen TL, Holm S, Loft A, Berthelsen AK, Ploug M, Pappot H, Brasso K, Kroman N, Hojgaard L, Kjaer A. First-in-human uPAR PET: Imaging of Cancer Aggressiveness. Theranostics. 2015 Sep 13;5(12):1303-16. doi: 10.7150/thno.12956. eCollection 2015.

Persson M, Nedergaard MK, Brandt-Larsen M, Skovgaard D, Jorgensen JT, Michaelsen SR, Madsen J, Lassen U, Poulsen HS, Kjaer A. Urokinase-Type Plasminogen Activator Receptor as a Potential PET Biomarker in Glioblastoma. J Nucl Med. 2016 Feb;57(2):272-8. doi: 10.2967/jnumed.115.161703. Epub 2015 Oct 1.

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