Trial Outcomes & Findings for Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors (NCT NCT01619865)
NCT ID: NCT01619865
Last Updated: 2021-07-27
Results Overview
Subject receives an injection of 68Ga-DOTATOC, a somatostatin-like peptide that binds to somatostatin receptor and is tagged with a radionuclide that can be detected by positron emission tomography (PET). Whole body PET is performed; patient is queried regarding any adverse events immediately and again 24 hrs after completion of scan read by certified nuclear medicine physician to determine if any known tumor lesions take up 68Ga-DOTATOC.Severity of adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Adverse events are assessed immediately after PET scan and 24 hrs after completion of the scan.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
223 participants
Primary outcome timeframe
During PET scan and 24 hours post scan
Results posted on
2021-07-27
Participant Flow
Participants were recruited from the University of Iowa Holden Comprehensive Cancer Center Clinics and University of Iowa Children's Hospital. Participants being seen for known or suspected somatostatin receptor positive tumors were recruited for the study. Malignancies included neuroblastoma, medulloblastoma, and pheochromocytoma.
Female subjects of childbearing potential were given a pregnancy test (serum) prior to receiving research-related radiation. A women who was pregnant could not participate in the study.
Participant milestones
| Measure |
68Ga-DOTATOC PET/CT
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Overall Study
STARTED
|
223
|
|
Overall Study
COMPLETED
|
219
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
68Ga-DOTATOC PET/CT
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
|
Overall Study
subject not able to comply
|
1
|
Baseline Characteristics
Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors
Baseline characteristics by cohort
| Measure |
68Ga-DOTATOC PET/CT
n=223 Participants
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
182 Participants
n=5 Participants
|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
215 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
223 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During PET scan and 24 hours post scanPopulation: Subjects who reported an adverse event and relationship of adverse event to study drug (68Ga-DOTATOC). Several subjects reported more than one adverse event; thus, the number of subjects who experienced an event will be less than the number of events.
Subject receives an injection of 68Ga-DOTATOC, a somatostatin-like peptide that binds to somatostatin receptor and is tagged with a radionuclide that can be detected by positron emission tomography (PET). Whole body PET is performed; patient is queried regarding any adverse events immediately and again 24 hrs after completion of scan read by certified nuclear medicine physician to determine if any known tumor lesions take up 68Ga-DOTATOC.Severity of adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). Adverse events are assessed immediately after PET scan and 24 hrs after completion of the scan.
Outcome measures
| Measure |
68Ga-DOTATOC PET/CT
n=105 Participants
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
Possibly related
|
18 Adverse events reported
|
|
To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
Probably related
|
1 Adverse events reported
|
|
To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
Unlikely related
|
6 Adverse events reported
|
|
To Measure Safety of 68Ga-DOTATOC Positron Emission Tomography (PET) by Measuring the Number of Adverse Events Related to the Investigational Radiopharmaceutical Agent
Unrelated
|
157 Adverse events reported
|
PRIMARY outcome
Timeframe: Up to 6 monthsNumber of subjects with adverse events related to the use of the 68Ga-DOTATOC radiopharmaceutical in accordance with National Cancer Institute (NCI) toxicity guidelines (NCI Common Terminology Criteria for Adverse Events version 4.0)
Outcome measures
| Measure |
68Ga-DOTATOC PET/CT
n=223 Participants
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC
Number of subjects with no adverse events (AE)
|
118 Participants
|
|
Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC
Number of subjects with Grade 1 or 2 AE
|
101 Participants
|
|
Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC
Number of subjects with Grade 3 AE
|
4 Participants
|
|
Number of Subjects With Adverse Events Related to the Use of the 68Ga-DOTATOC
Number of subjects with Grade 4 or 5 AE
|
0 Participants
|
Adverse Events
68Ga-DOTATOC PET/CT
Serious events: 1 serious events
Other events: 176 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
68Ga-DOTATOC PET/CT
n=223 participants at risk
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized of specific area (not due to neuropathy - Whole body/generalized
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
General disorders
Pain NOS
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
Other adverse events
| Measure |
68Ga-DOTATOC PET/CT
n=223 participants at risk
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
68Ga-DOTATOC PET/C: 1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
|
|---|---|
|
Hepatobiliary disorders
Hemoglobin
|
5.4%
12/223 • Number of events 12 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Hepatobiliary disorders
Leukocytes (total WBC)
|
1.8%
4/223 • Number of events 4 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Hepatobiliary disorders
Lymphopenia
|
4.9%
11/223 • Number of events 11 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Hepatobiliary disorders
Platelets
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.3%
3/223 • Number of events 3 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
General disorders
Sweating (diaphoresis)
|
3.1%
7/223 • Number of events 7 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
1.3%
3/223 • Number of events 3 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.7%
6/223 • Number of events 6 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction/extravasation changes
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.2%
5/223 • Number of events 5 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Gastrointestinal disorders
Constipation
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
15/223 • Number of events 15 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
General disorders
Gastrointestinal - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
13/223 • Number of events 13 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
4/223 • Number of events 5 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Blood and lymphatic system disorders
Edema: limb
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
3.1%
7/223 • Number of events 7 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.8%
13/223 • Number of events 13 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.3%
3/223 • Number of events 3 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Metabolism and nutrition disorders
Creatinine
|
2.2%
5/223 • Number of events 5 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-upper
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Nervous system disorders
Cognitive disturbance
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Nervous system disorders
Dizziness
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Nervous system disorders
Neuropathy: sensory
|
2.2%
5/223 • Number of events 5 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Eye disorders
Ocular/Visual - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Eye disorders
Vision-blurred vision
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Eye disorders
Vision-flashing lights/floaters
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Abdomen NOS
|
4.9%
11/223 • Number of events 13 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
2.7%
6/223 • Number of events 6 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
1.3%
3/223 • Number of events 3 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
3.1%
7/223 • Number of events 7 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Nervous system disorders
Pain - Head/headache
|
1.8%
4/223 • Number of events 4 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
General disorders
Pain - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain - Throat/pharynx/larynx
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.3%
3/223 • Number of events 3 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function - Other (Specify, __)
|
0.45%
1/223 • Number of events 1 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
|
Musculoskeletal and connective tissue disorders
Pain-neck
|
0.90%
2/223 • Number of events 2 • From time of study drug injection, through PET scan up to 24 hours post injection.
|
Additional Information
Sue O'Dorisio, MD, PhD
University of Iowa Holden Comprehensive Cancer Center
Phone: 319-356-7873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place