Study on Copper Cu 64 Dotatate for Detecting and Monitoring Neuroendocrine Tumors (NETs)

Sponsor: Curium US LLC

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04334837

Provider View

This clinical trial provides access to Copper Cu 64 Dotatate, a new imaging agent, for patients with neuroendocrine tumors (NETs) who couldn't participate in the earlier Phase 3 Trial. The study aims to help detect and monitor these tumors.

Patient Parameters

Program Overview

The purpose of this study is to offer patients with confirmed or suspected neuroendocrine tumors (NETs) access to Copper Cu 64 Dotatate. This imaging agent helps in detecting and monitoring NETs that express a specific marker called SSTR. The study bridges the gap between clinical trials and the availability of the product after FDA approval.

Description

This trial is designed to provide access to Copper Cu 64 Dotatate for patients with neuroendocrine tumors (NETs) who need help in detecting and monitoring their condition. The imaging agent works by highlighting tumors that express a specific marker, making it easier for doctors to locate and assess them. This study is especially for those who couldn't participate in the earlier Phase 3 Trial and aims to ensure patients can benefit from this new technology while it becomes more widely available.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Willing to sign a consent form and follow the study procedures.
  • Must meet at least one of the following:
    • Have a confirmed or suspected NET based on a biopsy or imaging scans like MRI, CT, or PET-CT done within 8 weeks before the study.
  • Women of childbearing age must have a negative pregnancy test before the study and agree to use non-hormonal birth control or abstain from sex for at least 2 weeks after the study.
  • Men must agree to use birth control or abstain from sex for at least 2 weeks after the study.
  • Recent blood tests must show:
    • White blood cells >2 x 10^9/L
    • Hemoglobin >8.0g/dL
    • Platelets >50 x 10^9/L
    • Liver enzymes (ALT, AST, AP) ≤5 times the normal limit
    • Bilirubin ≤3 times the normal limit
    • Serum creatinine <170 μmol/L

Exclusion Criteria

  • Pregnant or planning to become pregnant within the next two weeks.
  • Recent use of certain medications like Sandostatin® LAR or Lanreotide within 28 days, or Sandostatin® within 2 days before the study.
  • Significant blood disorders or immune system issues.
  • Breastfeeding women.
  • Serious health conditions like uncontrolled heart failure, liver or kidney problems, or high blood pressure.
  • Allergies to similar drugs or ingredients in the study product.
  • History of drug abuse within the past year.
  • Participation in other drug trials within 30 days before this study or unwilling to wait at least one week before joining another trial after this study.

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