Trial Outcomes & Findings for Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors (NCT NCT01967537)
NCT ID: NCT01967537
Last Updated: 2019-11-19
Results Overview
Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
COMPLETED
PHASE2
341 participants
During PET Scan, up to 2 hours annually for up to 5 years
2019-11-19
Participant Flow
Participant milestones
| Measure |
68Gallium DOTATATE Imaging
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
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|---|---|
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Overall Study
STARTED
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341
|
|
Overall Study
COMPLETED
|
281
|
|
Overall Study
NOT COMPLETED
|
60
|
Reasons for withdrawal
| Measure |
68Gallium DOTATATE Imaging
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
52
|
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Overall Study
Refuse treatment
|
2
|
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Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
68Gallium DOTATATE Imaging
n=341 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Age, Categorical
<=18 years
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1 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
238 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
102 Participants
n=93 Participants
|
|
Age, Continuous
|
55.89 years
STANDARD_DEVIATION 14.43 • n=93 Participants
|
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Sex: Female, Male
Female
|
194 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Race Unknown
|
9 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
290 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
323 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Ethnicity Unknown
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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341 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: During PET Scan, up to 2 hours annually for up to 5 yearsPopulation: Analysis was performed in the initial 131/341 participants scanned because 52 withdrew consent and 2 refused treatment. Subsequent scans in the remaining 156 participants were used to assess secondary objectives.
Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=131 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
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Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan
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847 Number of lesions
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SECONDARY outcome
Timeframe: During radioguided surgery, up to 2 hoursPopulation: As of 12/22/14 when the analysis was performed, 14/140 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed. 126 participants were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE and did not have radiation detector.
The radioactivity was assessed using intraoperative radiation detector following the 68Gallium-DOTATATE injection. Low grade neuroendocrine tumors is defined as tumors with slow cell division determined in histology. Low grade tumors is associated with the best outcome. Intermediate grade tumor is defined as the tumor with medium (3-20%) rate of actively dividing cells and is associated with less favorably outcome.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=14 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
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Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor
Low grade
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504.9 511KeV count per ten seconds
Standard Deviation 534
|
|
Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor
Intermediate grade
|
205 511KeV count per ten seconds
Standard Deviation 147
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SECONDARY outcome
Timeframe: During radioguided surgery, up to 2 hoursPopulation: 184/341 participants were analyzed because 52 withdrew consent and 2 refused treatment, 22 did not have a diagnosis of neuroendocrine tumor, and 81 had no 68Ga-DOTATATE uptake and were excluded.
Participants were scanned using the 68Gallium-DOTATATE Scan. Tumor volume more than 7ml is associated with shorter time to disease progression. Tumor volume more than 36 ml is associated with shorter disease specific survival.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=184 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan
|
9.24 ml
Interval 0.06 to 1136.7
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SECONDARY outcome
Timeframe: During PET Scan, up to 2 hours annuallyPopulation: As of 12/22/14 when the analysis was performed, 12/140 subj. required surgical intervention with intraoperative radiation detector \& thus were analyzed. 12 subj. had their tumors analyzed for the expression of SSTR, 126 subj. were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE \& did not have radiation detector.
High expression of somatostatin receptor 2 (SSTR2) is based on the intensity grading on immunohistochemistry. High SSTR2 expression may be associated with well-differentiated tumor and high avidity on DOTATATE scan, compared to intermediate or low expression of SSTR that can be seen in poorly differentiated and often aggressive neuroendocrine tumors. Because the correlation can only be from the comparison of preoperative DOTATATE and the tumors that were removed, it is a one time analysis. Subsequent DOTATATE studies are for surveillance and follow up for disease progression or recurrence.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=12 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2
High expression
|
6.5 Tumor to background ratio
Interval 3.4 to 14.9
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|
Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2
Low expression
|
3.7 Tumor to background ratio
Interval 3.5 to 6.3
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SECONDARY outcome
Timeframe: Radio-guided surgery, up to 2 hoursPopulation: As of 02.14.2018 when the analysis was performed, 44/326 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed for the number of tumors identified. 282 participants were not surgical candidates and did not receive intraoperative dose of 68 Gallium-DOTATATE and did not have radiation detector used.
Radio-guided surgery in neuroendocrine tumors using 68Gallium-DOTATATE was performed to detect tumors in the stomach and small bowel neuroendocrine tumors, pancreas, metastatic sites to lymph nodes and liver, and pheochromocytoma or paraganglioma. The number of tumors identified by the radiation detector were assessed.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=44 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
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The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Stomach and small bowel
|
23 Number of tumors
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The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Pancreas tumors
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24 Number of tumors
|
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The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Pheochromocytoma and paraganglioma
|
6 Number of tumors
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The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Liver metastasis
|
9 Number of tumors
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The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE
Metastatic lymph nodes
|
71 Number of tumors
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 50 months and 17 days.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
68Gallium DOTATATE Imaging
n=341 Participants
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
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21 Participants
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Adverse Events
68Gallium DOTATATE Imaging
Serious adverse events
| Measure |
68Gallium DOTATATE Imaging
n=341 participants at risk
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Vascular disorders
Thromboembolic event
|
0.88%
3/341 • Number of events 3 • Date treatment consent signed to date off study, approximately 50 months and 17 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.29%
1/341 • Number of events 1 • Date treatment consent signed to date off study, approximately 50 months and 17 days.
|
|
General disorders
Death (unrelated to 68 Gallium DOTATATE)
|
4.7%
16/341 • Number of events 16 • Date treatment consent signed to date off study, approximately 50 months and 17 days.
|
Other adverse events
| Measure |
68Gallium DOTATATE Imaging
n=341 participants at risk
68Gallium DOTATATE imaging
68Gallium DOTATATE: Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Radio-guided surgery: Using 68Gallium DOTATATE
|
|---|---|
|
Nervous system disorders
Alteration of consciousness
|
0.29%
1/341 • Number of events 1 • Date treatment consent signed to date off study, approximately 50 months and 17 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place