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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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28 November 2016 |
Main ID: |
NCT02970786 |
Date of registration:
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15/11/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
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Scientific title:
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Date of first enrolment:
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November 2016 |
Target sample size:
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10 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02970786 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 1
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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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Malene M Clausen, MD, PhD |
Address:
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Telephone:
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+4522524536 |
Email:
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malene.martini.clausen@regionh.dk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
- Capable of understanding and giving full informed consent
Exclusion Criteria:
- Pregnancy
- Lactation
- Obesity (weight above 140 kg)
- Claustrophobia
Age minimum:
50 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neuroendocrine Carcinoma
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Breast Cancer
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Ovarian Cancer
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Intervention(s)
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Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2
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Primary Outcome(s)
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Biodistribution
[Time Frame: 2 hours]
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Dosimetry
[Time Frame: 2 hours]
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Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.
[Time Frame: 48 hours]
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Secondary Outcome(s)
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Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue
[Time Frame: 2 hours]
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Secondary ID(s)
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AK-2015-1
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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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