Clinical trial NCT02960724: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Official title: Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Cancer
Oropharyngeal Cancer
Neoplasms
Head and Neck Neoplasms
Cancer of Mouth
Neoplasms by Site
Keywords: Uroplasminogen Plasminogen Activator Receptor
Oropharyngeal cancer
oral cancer
Positron Emission Tomography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 +).

Eligibility criteria: 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

Primary outcomes:
measure: The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.
timeFrame: Through study completion, an average of 1.5 year
Secondary outcomes:
measure: 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).
timeFrame: Through study completion, an average of 1.5 year
measure: 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.
timeFrame: Through study completion, an average of 1.5 year
measure: 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)
timeFrame: Through study completion, an average of 1.5 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
name: Andreas Kjær, MD,DMSc,PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.