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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04334837 on ClinicalTrials.gov