Clinical trial NCT01879657: 68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroendocrine Carcinoma
Lead sponsor: Radio Isotope Therapy of America
Sponsor class: OTHER
Collaborators: name: Radiomedix, Inc.
name: Excel Diagnostics and Nuclear Oncology Center
First posted: 2013-06-18
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
timeFrame: SOT within 28 days before 68Ga-DOTATATE PET/CT scan
Secondary outcomes:
measure: Frequency and severity of Adverse Events
timeFrame: 4 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Radio- Isotope Therapy of America
state: Texas
Study officials:
affiliation: Radiomedix, Inc.
name: Ebrahim Delpassand, MD
role: PRINCIPAL_INVESTIGATOR
References: