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

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ClinicalTrials.gov Identifier: NCT02960724
Recruitment Status : Unknown
Verified November 2016 by Kirstine Karnov, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : November 10, 2016
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):
Kirstine Karnov, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Oral Cancer Oropharyngeal Cancer Neoplasms Head and Neck Neoplasms Cancer of Mouth Neoplasms by Site Other: 68Ga-NOTA-AE105 PET/CT Phase 2

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 +).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Trial: uPAR PET/CT for Staging Advanced and Localised Oral and Oropharyngeal Cancer
Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960724


Locations
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Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Kirstine KS Karnovs, MD    +4526227128    Kirstine.kim.schmidt.karnov@regionh.dk   
Contact: Andreas Kjær, MD,DMSc,PhD    +4535454011    akjaer@sund.ku.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Director: Andreas Kjær, MD,DMSc,PhD Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Publications of Results:
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Responsible Party: Kirstine Karnov, MD, PhD-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02960724    
Other Study ID Numbers: AK-2016-HHC1
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kirstine Karnov, Rigshospitalet, Denmark:
Uroplasminogen Plasminogen Activator Receptor
Oropharyngeal cancer
oral cancer
Positron Emission Tomography
Additional relevant MeSH terms:
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Neoplasms
Head and Neck Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Mouth Diseases