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

NCT ID: NCT01879657

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2017-12-05

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.

Detailed Description

The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.

Conditions

Neuroendocrine Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-DOTATATE

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

Group Type: EXPERIMENTAL

68Ga-DOTATATE

Intervention Type: 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.

PET/CT

Intervention Type: 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.

111In-pentetreotide OctreoScan

Intervention Type: 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.

MRI

Intervention Type: DIAGNOSTIC_TEST

MRI (Standard of Care)

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

MRI

MRI (Standard of Care)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Gallium-68 DOTATATE; [⁶⁸Ga]-DOTA-Tyr3-Octreotate; 68Ga DOTA-TATE; PET-CT Scan; Magnetic Resonance Imaging (MRI)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiomedix, Inc.

INDUSTRY

Sponsor Role: collaborator

Excel Diagnostics and Nuclear Oncology Center

OTHER

Sponsor Role: collaborator

Radio Isotope Therapy of America

OTHER

Sponsor Role: lead

Responsible Party

Ebrahim Delpassand

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebrahim Delpassand, MD

Role: PRINCIPAL_INVESTIGATOR

Radiomedix, Inc.

Locations

Radio- Isotope Therapy of America

Houston, Texas, United States

Countries

United States

Other Identifiers

117289

Identifier Type: -

Identifier Source: org_study_id