NCT03673943

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

Completed Phase 3 Results posted Last updated 22 December 2022

What this trial tests

Phase 3 trial testing 64Cu-DOTATATE in Neuroendocrine Tumors in 63 participants. Completed in 7 August 2019.

Timeline

23 August 2018

Primary endpoint
23 March 2019

7 August 2019

Quick facts

Lead sponsor	Radiomedix, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	63
Start date	23 August 2018
Primary completion	23 March 2019
Estimated completion	7 August 2019
Sites	1 location across United States

Drugs / interventions tested

• 64Cu-DOTATATE — full drug profile →

Conditions studied

• Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →

Sponsor

Radiomedix, Inc. — full company profile →

Who can join

18 and older, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sensitivity of 64Cu-DOTATATE PET-CT Imaging for Detection of Somatostatin Receptor Positive SSTR (+) Tumor Primary · 12 months

The number of patients with NETs disease that was confirmed by SSTR(+) imaging using 64Cu-DOTATATE PET/CT and In111-Octreoscan (considered as the standard of truth imaging) A total of 63 subjects have been enrolled in the studies; among them 42 patients with known or suspected NET based on histology, or conventional imaging, or clinical evaluations and 21 healthy volunteers.

true positive

Group	Value	95% CI
PET/CT Imaging With 64Cu-DOTATATE	30

false negative

Group	Value	95% CI
PET/CT Imaging With 64Cu-DOTATATE	3

Specificity of 64Cu- DOTATATE PET/CT Imaging for Detection of Neuroendocrine Tumor Primary · 12 months

The number of subjects who have no SSTR (+) NETs as determined by 64Cu-DOTATATE PET/CT as well using the standard of truth imaging (In111-Octrescan SPECT/CT).

true negative

Group	Value	95% CI
PET/CT Imaging With 64Cu-DOTATATE	28

false positive

Group	Value	95% CI
PET/CT Imaging With 64Cu-DOTATATE	1

Detection of Localized or Metastatic SSTR Positive NETs Lesions Using Both 64Cu-DOTATATE PET/CT and Standard of Truth Imaging Secondary · 12 months

The number of patients with localized NETs or metastatic SSTR(+) neuroendocrine tumors that were detected by both 64Cu-DOTATATE and SOT

Group	Value	95% CI
PET/CT Imaging With 64Cu-DOTATATE	2
PET/CT Imaging With 64Cu-DOTATATE	0
PET/CT Imaging With 64Cu-DOTATATE	0
PET/CT Imaging With 64Cu-DOTATATE	28

Adverse events — posted to ClinicalTrials.gov

Time frame: Any adverse events observed or reported were recorded for up to 48 hours following study drug administration. In addition, observed or patient reported immediate adverse events including but not limited to pain, injection site reaction, headache, nausea, vomiting, flushing or other as reported, were assessed within 1 hour before and within 2 hours after the study drug administration. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PET/CT Imaging With 64Cu-DOTATATE

Serious: 0/63 (0%)

Deaths: 0/63

Other adverse events (6 terms — click to expand)

Reaction	System	PET/CT Imaging With 64Cu-D…
vomiting (both grade 1)	General disorders	—
nausea (grade 1)	Gastrointestinal disorders	—
headache (grade 1)	General disorders	—
syncope (grade 2)	General disorders	—
melanoderma (grade 1)	General disorders	—
flushing (grade 1)	General disorders	—

Data from ClinicalTrials.gov NCT03673943 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pancreatic endocrine and exocrine signaling and crosstalk in physiological and pathological status.
   Hu C, Chen Y, Yin X, Xu R, et al · · 2025 · cited 25× · PMID 39948335 · DOI 10.1038/s41392-024-02098-3
2. <i>CopperNostics</i>-Here We Are Now, Entertain Us!
   Brühlmann SA, Walther M, Kopka K, Kreller M, et al · · 2026 · PMID 41754861 · DOI 10.3390/ph19020321