Trial Outcomes & Findings for Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC) (NCT NCT03273712)
NCT ID: NCT03273712
Last Updated: 2023-02-09
Results Overview
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Results posted on
2023-02-09
Participant Flow
The University of Iowa Neuroendocrine Tumor Registry includes over 1500 individuals with NETs who have signed consent to be contacted when new clinical trials are available. The University of Iowa Children's Hospital has children with neuroblastoma and medulloblastoma (or other brain tumor) and neuroendocrine tumor who may be interested; in this case, participation would be offered only if/when the child failed conventional therapy.
A subject can have the 90Y-DOTATOC treatment the next day after he/she signs the consent. Administration of 90Y-DOTATOC will likely be 12 hours to 1 month following confirmation of positive lesions on 68Ga-DOTATOC PET scan.
Participant milestones
| Measure |
90Y-DOTA-tyr3-Octreotide
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
90Y-DOTA-tyr3-Octreotide
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Overall Study
Death
|
5
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Disease Progression
|
1
|
Baseline Characteristics
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
Baseline characteristics by cohort
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 Participants
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.
Outcome measures
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 Participants
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Frequency of Tumor Response at 9 Months After Last Treatment
Complete Response
|
0 Participants
|
|
Frequency of Tumor Response at 9 Months After Last Treatment
Partial Response
|
1 Participants
|
|
Frequency of Tumor Response at 9 Months After Last Treatment
Stable Disease
|
19 Participants
|
|
Frequency of Tumor Response at 9 Months After Last Treatment
Progressive Disease
|
15 Participants
|
|
Frequency of Tumor Response at 9 Months After Last Treatment
Not Evaluable
|
4 Participants
|
PRIMARY outcome
Timeframe: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.
Outcome measures
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 Participants
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
|
0 Participants
|
PRIMARY outcome
Timeframe: Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.
Outcome measures
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 Participants
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
|
0 Participants
|
Adverse Events
90Y-DOTA-tyr3-Octreotide
Serious events: 14 serious events
Other events: 37 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 participants at risk
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Cardiac disorders
Atrioventricular block complete
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Edema limbs
|
2.6%
1/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Pain
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Bronchial infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Catheter related infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Sepsis
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Blood bilirubin increased
|
2.6%
1/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Creatinine increased
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Platelet count decreased
|
2.6%
1/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Headache
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
Other adverse events
| Measure |
90Y-DOTA-tyr3-Octreotide
n=39 participants at risk
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
17.9%
7/39 • Number of events 7 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Cardiac disorders
Atrioventricular block complete
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
10.3%
4/39 • Number of events 5 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Eye disorders
Eye disorders - Other, specify
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
9/39 • Number of events 12 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
3/39 • Number of events 4 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Gastroparesis
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Nausea
|
94.9%
37/39 • Number of events 83 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
15/39 • Number of events 26 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Chills
|
7.7%
3/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Edema face
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Edema limbs
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Fatigue
|
38.5%
15/39 • Number of events 20 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Fever
|
12.8%
5/39 • Number of events 5 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Flu like symptoms
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Gait disturbance
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Infusion site extravasation
|
12.8%
5/39 • Number of events 6 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Injection site reaction
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Localized edema
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
General disorders
Pain
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Bronchial infection
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Catheter related infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Sepsis
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Skin infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Blood bilirubin increased
|
2.6%
1/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Creatinine increased
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Investigations - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Lymphocyte count decreased
|
12.8%
5/39 • Number of events 5 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Neutrophil count decreased
|
7.7%
3/39 • Number of events 6 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Platelet count decreased
|
10.3%
4/39 • Number of events 4 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
Weight gain
|
7.7%
3/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Investigations
White blood cell decreased
|
10.3%
4/39 • Number of events 8 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
3/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.1%
2/39 • Number of events 2 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Dizziness
|
15.4%
6/39 • Number of events 9 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Headache
|
20.5%
8/39 • Number of events 10 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Lethargy
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Paresthesia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Nervous system disorders
Syncope
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 3 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Psychiatric disorders
Insomnia
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Vascular disorders
Flushing
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Number of events 4 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.6%
1/39 • Number of events 1 • Adverse even documentation began after radiotracer injection and continues through 1 calendar day following imaging, up to approximately 10-13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place