68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

Radio Isotope Therapy of America

Status: Completed

Conditions: Neuroendocrine Carcinoma

Treatments: Diagnostic Test: 68Ga-DOTATATE injection and PET scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01879657

117289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

169 participants in 1 patient group

68Ga-DOTATATE PET scans

Experimental group

Description:

This is an open-label, single-dose diagnostic study using DOTATATE peptide, labelled with the 68Ga tracer. The radiation (imaging) dose will be 111-185MBq (3 - 5 mCi) ±25%. Imaging will start 90 ±30 minutes after injection. The diagnostic sensitivity, specificity and accuracy of the study drug are being compared with a predefined standard of truth (SOT) parameters. A comparative conventional scan, such as anatomical imaging modalities CT, ultrasound, and MRI or functional imaging using 18F-FDG and NaF PET/CT or bone scan is being used to evaluate the diagnostic efficacy of 68Ga-DOTATATE.

Treatment:

Diagnostic Test: 68Ga-DOTATATE injection and PET scan