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Trial record 24 of 1330 for:    Recruiting, Not yet recruiting, Available Studies | "Head and Neck Neoplasms"

Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer

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ClinicalTrials.gov Identifier: NCT02965001
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Louise Madeleine Risør, Rigshospitalet, Denmark

Brief Summary:

Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted.

One of the hallmarks in cancer is the ability to invade the surrounding tissue and metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA) and its receptor (uPAR) are present at the very front of the invasive tumor and they are considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer offers a very promising target for functional PET imaging and may be a stronger prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this project all participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate and mortality at routine clinical follow-up.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: 68Ga-NOTA-AE105 Phase 2

Detailed Description:

In this study all included patients with head and neck cancer (HNC) have an uPAR-PET/CT scan performed before the initiation of the curative intended radiotherapy. After the radiotherapy treatment the patients attend the routine clinical follow-up programme at Rigshospitalet to follow the loco-regional control, signs of metastasis and the overall survival. These relapse- and survival parameters will be correlated to the SUVmax, SUVmean and the TNM stage obtained from the uPAR scan and will be compared to the findings on the routine FDG scan to clarify which tracer is the strongest prognostic marker in HNC.

If any previous tissue samples have been taken from the tumour before the patient enters the study the uPAR immunohistopathology of the tissue sample will be compared to the uPAR-PET/CT findings. We will not perform any biopsies or tissue samples in this study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-NOTA-AE105
All participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy
Drug: 68Ga-NOTA-AE105
The patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up.
Other Name: uPAR




Primary Outcome Measures :
  1. Freedom from any failure [ Time Frame: 1-3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 1-3 years ]
  2. Disease free survival [ Time Frame: 1-3 years ]
  3. Distant metastasis free survival [ Time Frame: 1-3 years ]
  4. Loco-regional control [ Time Frame: 1-3 years ]


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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:The patient

  • has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity
  • is referred to curative intended radiotherapy
  • understands the given information and has given informed consent and
  • age above 18 years.

Exclusion Criteria:

Pregnancy, lactation/breast feeding, age above 85 years, obesity (bodyweight above 140 kg), small cancers of the larynx (1A,1B), allergy to 68Ga-NOTA-AE105, metastasis on FDG-PET/CT, other previously known cancers, claustrophobia.


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): NCT02965001


Contacts
Contact: Louise Madeleine Risør, MD 29896610 ext 0045 louise.madeleine.risoer@gmail.com
Contact: Andreas Kjær, Professor 35455011 ext 0045 akjaer@sund.ku.dk

Locations
Denmark
Departmen of Physiology, Nuclear Medicine and PET, Rigshospitalet, Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Louise Madeleine Risør, MD    29896610    louise.madeleine.risoer@gmail.com   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Andreas Kjær, Professor Rigshospitalet, Denmark

Responsible Party: Louise Madeleine Risør, Principal investigator, medical doctor, Ph.D student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02965001     History of Changes
Other Study ID Numbers: 366_16
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Louise Madeleine Risør, Rigshospitalet, Denmark:
Molecular Imaging
uPAR-PET/CT
Head and neck cancer
curative intended radiotherapy

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms