Trials / Approved For Marketing
Approved For MarketingNCT04334837
Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of SSTR Expressing (NETs)
An Open-Label, Multi-Center Expanded Access Protocol of Copper Cu 64 Dotatate for the Detection, Localization and Monitoring of Somatostatin Receptor Expressing Neuroendocrine Tumors (NETs)
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Curium US LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Detailed description
The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of SSTR expressing NETs, bridging the gap between investigational product availability in clinical studies and marketed product availability following US Food and Drug Administration (FDA) approval.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- First posted
- 2020-04-06
- Last updated
- 2020-10-09
Source: ClinicalTrials.gov record NCT04334837. Inclusion in this directory is not an endorsement.