Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)
NCT04334837 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2020-10-09
Summary
This is an open-label, multi-center expanded access program designed to provide access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of NETs to patients that did not have access during the Phase 3 Trial.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
Copper Cu 64 Dotatate
The drug product contains Copper Cu 64 Dotatate filled in a glass vial, closed with butyl rubber stopper secured with an aluminum crimp seal. The drug product will be delivered by Curium to the clinical site. The EAP drug will be administered as an intravenous bolus injection. The dose will be administered according to the schedule detailed in the protocol.
Sponsors & Collaborators
-
Curium US LLC
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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