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68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)

NCT01879657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2025-08-06

No results posted yet for this study

Summary

To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

68Ga-DOTATATE

68Ga-DOTATATE (3-5 mCi ±25%; 111-185 MBq) is administered as a single intravenous bolus injection in each participant. These injections were performed within 28 days after the Octreoscan.

DIAGNOSTIC_TEST

PET/CT

68Ga-DOTATATE PET images will be acquired 60 ±30 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET images were performed within 28 days after the Octreoscan.

DIAGNOSTIC_TEST

111In-pentetreotide OctreoScan

OctreoScan™ was performed after intravenous injection of 111In-pentetreotide, a radiopharmaceutical that binds to somatostatin receptors, if the patient had not undergone such imaging as a standard of care. Subsequent planar and/or SPECT imaging was used to detect somatostatin receptor-positive lesions.

DIAGNOSTIC_TEST

MRI

MRI (Standard of Care)

Sponsors & Collaborators

  • Radiomedix, Inc.

    collaborator INDUSTRY

  • Excel Diagnostics and Nuclear Oncology Center

    collaborator OTHER

  • Radio Isotope Therapy of America

    lead OTHER

Principal Investigators

  • Ebrahim Delpassand, MD · Radiomedix, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2015-12-30
Completion
2017-12-05

Countries

  • United States

Study Locations

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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 NCT01879657 on ClinicalTrials.gov