Phase 3 N=63 Diagnostic

Imaging of Patients With Known or Suspected Somatostatin Receptor Positive Neuroendocrine Tumors Using Cu64-DOTATATE

Neuroendocrine Tumors

Bottom Line

View on ClinicalTrials.gov: NCT03673943 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2022

Primary outcome: Primary: Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor — 30; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 64Cu-DOTATATE (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radiomedix, Inc.
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor	30; 3	—
PRIMARY Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor	28; 1	—
SECONDARY Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging	2; 0; 0; 28	—

Summary

This is an open-label, single-dose, single-arm, single-center imaging study using DOTATATE peptide, labelled with the 64Cu tracer.

Eligibility Criteria

Inclusion Criteria

Confirmed or suspicion of NET based on histology/ biopsy report.
Confirmed or suspicion of NET based on conventional imaging scans of affected area such as MRI and/or contrast enhanced CT and/or an FDG PET
CT scan and/or NaF PET-CT scan and/or OctreoScan® performed within 8 weeks prior to study date.

Exclusion Criteria

Pregnant, planning to be pregnant within the next two weeks
Inability to provide written consent.
Therapeutic use of any somatostatin analogue, including Sandostatin® long-acting and Lanreotide (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a subject is on Sandostatin® long-acting or Lanreotide, a wash-out period of 28 days is required before the injection of the study drug.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03673943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.