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

Rigshospitalet, Denmark90 enrolled

Overview

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

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 +).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Oral Cancer Oropharyngeal Cancer Neoplasms Head and Neck Neoplasms Cancer of Mouth Neoplasms by Site

Interventions

68Ga-NOTA-AE105 PET/CTOTHER

One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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