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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
Intervention: 68Ga-DOTATATE (Drug)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
Intervention: PET/CT (Diagnostic Test)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
Intervention: 111In-pentetreotide OctreoScan (Diagnostic Test)
68Ga-DOTATATE
All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
Intervention: MRI (Diagnostic Test)
Outcomes
Primary Outcomes
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
Time Frame: SOT within 28 days before 68Ga-DOTATATE PET/CT scan
We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
Secondary Outcomes
- Frequency and severity of Adverse Events(4 days)
Investigators
Ebrahim Delpassand
President
Radio Isotope Therapy of America