Trial Outcomes & Findings for Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors (NCT NCT02441062)
NCT ID: NCT02441062
Last Updated: 2020-12-21
Results Overview
Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
36 months
Results posted on
2020-12-21
Participant Flow
Participant milestones
| Measure |
68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
|
|---|---|
|
Overall Study
STARTED
|
122
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
68Ga-DOTATOC PET/CT
n=122 Participants
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Study stopped early, 114 of the 122 patients enrolled were analyzed for outcome measure
Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET.
Outcome measures
| Measure |
68Ga-DOTATOC PET/CT
n=114 Participants
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
|
|---|---|
|
Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan
Major change
|
54 Participants
|
|
Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan
Minor change
|
6 Participants
|
|
Number of Participants With a Change in Treatment Management Based on Findings of the Gallium Ga 68-edotreotide PET/CT Scan
No change
|
54 Participants
|
Adverse Events
68Ga-DOTATOC PET/CT
Serious events: 0 serious events
Other events: 42 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
68Ga-DOTATOC PET/CT
n=122 participants at risk
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
68Ga-DOTATOC PET/CT: Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.82%
1/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Bloating
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Diarrhea
|
5.7%
7/122 • Number of events 8 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Flatulence
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
8/122 • Number of events 11 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
1/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
General disorders
Fever
|
1.6%
2/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
General disorders
Pain
|
1.6%
2/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
3/122 • Number of events 3 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
1.6%
2/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Nervous system disorders
Dizziness
|
2.5%
3/122 • Number of events 3 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Nervous system disorders
Dysgeusia
|
0.82%
1/122 • Number of events 1 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Nervous system disorders
Headache
|
2.5%
3/122 • Number of events 3 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Nervous system disorders
Paresthesia
|
0.82%
1/122 • Number of events 2 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
|
Vascular disorders
Flushing
|
2.5%
3/122 • Number of events 3 • Adverse events collected at the time of scan, 1 day post scan, and 6-18 months post scan.
|
Additional Information
M.Sue O'Dorisio
University of Iowa, Holden Comprehensive Cancer Center
Phone: (319) 335-7234
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place