Trial Outcomes & Findings for Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT (NCT NCT01869725)
NCT ID: NCT01869725
Last Updated: 2021-09-22
Results Overview
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)
Results posted on
2021-09-22
Participant Flow
Participant milestones
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
64
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Overall Study
ineligible after registration
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
Baseline characteristics by cohort
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
n=68 Participants
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 eligible participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)Population: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
n=34 Participants
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for OctreoScan as Compared to Pathology · False negative
|
6 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for OctreoScan as Compared to Pathology · Total negative
|
5 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology · Total positive
|
28 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology · False position
|
0 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology · False negative
|
1 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for Ga-68-DOTATOC as Compared to Pathology · Total negative
|
5 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for OctreoScan as Compared to Pathology · Total positive
|
23 Participants
|
|
Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
Sensitivity and Specificity for OctreoScan as Compared to Pathology · False position
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
Compare sensitivity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
n=34 Participants
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Sensitivity of Ga-68-DOTATOC
|
96.55 percentage of sensitivity
|
|
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Sensitivity of OctreoScan
|
79.31 percentage of sensitivity
|
|
Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
Sensitivity of Conventional Imaging (CI)
|
82.24 percentage of sensitivity
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients with neuroendocrine tumor or other somatostatin receptor positive tumor
Compare specificity of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors
Outcome measures
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
n=34 Participants
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Specificity of 68Ga-DOTATOC
|
100 percentage of specificity
|
|
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Specificity of Octreoscan
|
100 percentage of specificity
|
|
Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
Specificity of Conventional Imaging (CI)
|
47.82 percentage of specificity
|
Adverse Events
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (Gallium Ga 68-edotreotide PET/CT)
n=68 participants at risk
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
gallium Ga 68-edotreotide: Given IV
positron emission tomography/computed tomography: Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography: Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging: Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
2/68 • Number of events 2 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.5%
1/68 • Number of events 1 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Gastrointestinal disorders
Nausea
|
5.9%
4/68 • Number of events 4 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.5%
1/68 • Number of events 1 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
General disorders
Pain
|
2.9%
2/68 • Number of events 2 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
3/68 • Number of events 3 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
1.5%
1/68 • Number of events 1 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.5%
1/68 • Number of events 1 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Vascular disorders
Flushing
|
2.9%
2/68 • Number of events 2 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.5%
1/68 • Number of events 1 • Adverse events were collected over 6 months at the following time points: 1) screening visit which occurred within 30 days of Ga-68 DOTATOC PET/CT 2) at scan 1 3) 1-7 days post scan 1 4) at scan 2 5) 1-7 days post scan 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place