Back to results68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
Primary Purpose
Neuroendocrine Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
68Ga-DOTATATE injection and PET scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients of either gender, aged at least 18 years.
- Karnofsky status equal or greater than 60.
- Life expectancy of at least 12 weeks.
- Histologically and/or clinically confirmed and/or suspicious of NET.
- Somatostatin-analogue scintigraphies scan with result (positive or negative) within the last 4 weeks.
- Recent Blood test results up to 2-3 weeks as follows:(WBC:equal/higher 2*109/L; Haemoglobin: equal/higher 8.0g/Dl; Platelets: equal/higher 50x109/L; ALT, AST, AP: equal/lower 5 times ULN; Bilirubin: equal/lower 3 times ULN; Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
- Negative 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.
Sites / Locations
- Radio- Isotope Therapy of America
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-DOTATATE PET scans
Arm 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01879657
First Posted
April 11, 2013
Last Updated
March 24, 2023
Sponsor
Radio Isotope Therapy of America
Collaborators
Radiomedix, Inc., Excel Diagnostics and Nuclear Oncology Center
1. Study Identification
Unique Protocol Identification Number
NCT01879657
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radio Isotope Therapy of America
Collaborators
Radiomedix, Inc., Excel Diagnostics and Nuclear Oncology Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTATATE PET scans
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-DOTATATE injection and PET scan
Intervention Description
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
Primary Outcome Measure Information:
Title
Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
Description
We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
Time Frame
SOT within 28 days before 68Ga-DOTATATE PET/CT scan
Secondary Outcome Measure Information:
Title
Frequency and severity of Adverse Events
Description
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.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebrahim Delpassand, MD
Organizational Affiliation
Radiomedix, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radio- Isotope Therapy of America
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
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