Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
NCT ID: NCT02970786
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2016-11-30
Brief Summary
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This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
Detailed Description
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This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E\[c(RGDyK)\]2. In addition, the quantitative uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga-NODAGA-E(c[RGDyK])2 PET
One injection of 68Ga-NODAGA-E(c\[RGDyK\])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection
Injection of 68Ga-NODAGA-E(c[RGDyK])2
Following one injection of 68Ga-NODAGA-E(c\[RGDyK\])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
Interventions
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Injection of 68Ga-NODAGA-E(c[RGDyK])2
Following one injection of 68Ga-NODAGA-E(c\[RGDyK\])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
Eligibility Criteria
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Inclusion Criteria
* Capable of understanding and giving full informed consent
Exclusion Criteria
* Lactation
* Obesity (weight above 140 kg)
* Claustrophobia
50 Years
85 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Malene Martini Clausen
Principal Investigator, MD, PhD
Locations
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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Other Identifiers
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AK-2015-1
Identifier Type: -
Identifier Source: org_study_id