uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
NCT ID: NCT02960724
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2016-11-30
2018-08-31
Brief Summary
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Detailed Description
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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 +).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
68Ga-NOTA-AE105 PET/CT
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
Interventions
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68Ga-NOTA-AE105 PET/CT
One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Kirstine Karnov
MD, PhD-student
Principal Investigators
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Andreas Kjær, MD,DMSc,PhD
Role: STUDY_DIRECTOR
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Locations
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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, , Denmark
Countries
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Facility Contacts
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Kirstine KS Karnovs, MD
Role: primary
Andreas Kjær, MD,DMSc,PhD
Role: backup
References
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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.
Other Identifiers
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AK-2016-HHC1
Identifier Type: -
Identifier Source: org_study_id