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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2022 |
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Main ID: |
NCT02965001 |
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Date of registration:
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14/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer
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Scientific title:
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Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer |
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Date of first enrolment:
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November 2016 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02965001 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Andreas Kjær, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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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.
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Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Head and Neck Cancer
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Intervention(s)
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Drug: 68Ga-NOTA-AE105
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Primary Outcome(s)
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Freedom from any failure
[Time Frame: 1-3 years]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: 1-3 years]
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Distant metastasis free survival
[Time Frame: 1-3 years]
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Loco-regional control
[Time Frame: 1-3 years]
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Disease free survival
[Time Frame: 1-3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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