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

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Brief Title

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

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 +).

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

The number of lymph node metastases that can be identified by means of uPAR PET / CT compared with the histological findings.

Secondary Outcome

 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).

Condition

Oral Cancer

Intervention

68Ga-NOTA-AE105 PET/CT

Study Arms / Comparison Groups

 68Ga-NOTA-AE105 PET/CT
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

90

Start Date

November 2016

Completion Date

August 2018

Primary Completion Date

August 2018

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

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Andreas Kjær, MD,DMSc,PhD, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT02960724

Organization ID

AK-2016-HHC1

Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark

Study Sponsor

Andreas Kjær, MD,DMSc,PhD, Study Director, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Verification Date

November 2016