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

NCT01879657 | Completed DMC

• 1 other identifier: 117289
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique

  We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).

  SOT within 28 days before 68Ga-DOTATATE PET/CT scan

Secondary Outcomes (1)

• Frequency and severity of Adverse Events

  4 days

Study Arms (1)

68Ga-DOTATATE

EXPERIMENTAL

All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.

Drug: 68Ga-DOTATATE; Diagnostic Test: PET/CT; Diagnostic Test: 111In-pentetreotide OctreoScan; Diagnostic Test: MRI

Interventions

68Ga-DOTATATE DRUG

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.

Also known as: Gallium-68 DOTATATE, [⁶⁸Ga]-DOTA-Tyr3-Octreotate, 68Ga DOTA-TATE

68Ga-DOTATATE

PET/CT DIAGNOSTIC_TEST

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.

Also known as: PET-CT Scan

68Ga-DOTATATE

111In-pentetreotide OctreoScan DIAGNOSTIC_TEST

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.

68Ga-DOTATATE

MRI DIAGNOSTIC_TEST

MRI (Standard of Care)

Also known as: Magnetic Resonance Imaging (MRI)

68Ga-DOTATATE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Subjects of either sex, aged ≥18 years
• Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day
• Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN \[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\], Bilirubin: ≤3 times ULN \[ULN for total bilirubin is 1.3mg/dL\]
• Serum creatinine: Serum creatinine: \<170 μmol/L
• egative pregnancy test in women capable of child-bearing

You may not qualify if:

• Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE
• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug
• Pregnant or breast-feeding women
• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Sponsors & Collaborators

• Radio Isotope Therapy of America: lead
• Radiomedix, Inc.: collaborator
• Excel Diagnostics and Nuclear Oncology Center: collaborator

Study Sites (1)

Radio- Isotope Therapy of America

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

gallium Ga 68 dotatate; Positron Emission Tomography Computed Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Ebrahim Delpassand, MD

  Radiomedix, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: June 18, 2013
• Study Start: March 1, 2013
• Primary Completion: December 30, 2015
• Study Completion: December 5, 2017
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)