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

Neuroendocrine Carcinoma Clinical Trial

Official title:

An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879657
• Other study ID #: 117289
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: December 5, 2017

Study information

• Verified date: March 2023
• Source: Radio Isotope Therapy of America
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 5, 2017
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma
• Neuroendocrine Tumors

Intervention

Diagnostic Test:
• 68Ga-DOTATATE injection and PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.

Locations

Country	Name	City	State
United States	Radio- Isotope Therapy of America	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Radio Isotope Therapy of America	Excel Diagnostics and Nuclear Oncology Center, Radiomedix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency and severity of Adverse Events	Adverse events will be collected from the time of 68Ga-DOTATATE injection until 48 hours post-injection visit. Adverse events will be classified using criteria for adverse events (CTCAE) Version 4.	4 days