Trial Outcomes & Findings for 68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer (NCT NCT02440308)

Last Updated: 2017-04-11

Results Overview

Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

1 hour

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	68Ga-DOTA-Bombesin PET/MRI Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	68Ga-DOTA-Bombesin PET/MRI n=10 Participants Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants
Age, Continuous	73.3 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Region of Enrollment United States	10 participants n=99 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: All participants were averaged to provide SUVmean uptake in normal organs.

Outcome measures

Outcome measures
Measure	68Ga-DOTA-Bombesin PET/MRI n=10 Participants Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Normal Biodistribution of 68Ga-DOTA-Bombesin Ascending aorta (blood pool)	2.28 SUV-mean Standard Deviation 0.68
Normal Biodistribution of 68Ga-DOTA-Bombesin Bladder	121.55 SUV-mean Standard Deviation 67.45
Normal Biodistribution of 68Ga-DOTA-Bombesin Brain cortex (frontal lobe)	0.08 SUV-mean Standard Deviation 0.04
Normal Biodistribution of 68Ga-DOTA-Bombesin Cerebellum	0.10 SUV-mean Standard Deviation 0.05
Normal Biodistribution of 68Ga-DOTA-Bombesin Cervical vertebrae	0.70 SUV-mean Standard Deviation 0.19
Normal Biodistribution of 68Ga-DOTA-Bombesin Choroid plexus	0.25 SUV-mean Standard Deviation 0.16
Normal Biodistribution of 68Ga-DOTA-Bombesin Colon	2.01 SUV-mean Standard Deviation 0.74
Normal Biodistribution of 68Ga-DOTA-Bombesin Esophagus	4.08 SUV-mean Standard Deviation 1.51
Normal Biodistribution of 68Ga-DOTA-Bombesin Extra focal uptakes	12.72 SUV-mean Standard Deviation 7.77
Normal Biodistribution of 68Ga-DOTA-Bombesin Femur	0.34 SUV-mean Standard Deviation 0.12
Normal Biodistribution of 68Ga-DOTA-Bombesin Liver	1.94 SUV-mean Standard Deviation 0.48
Normal Biodistribution of 68Ga-DOTA-Bombesin Lung	0.48 SUV-mean Standard Deviation 0.16
Normal Biodistribution of 68Ga-DOTA-Bombesin Gluteal fat	0.60 SUV-mean Standard Deviation 0.19
Normal Biodistribution of 68Ga-DOTA-Bombesin Gluteal muscle	0.79 SUV-mean Standard Deviation 0.41
Normal Biodistribution of 68Ga-DOTA-Bombesin Humerus	0.53 SUV-mean Standard Deviation 0.17
Normal Biodistribution of 68Ga-DOTA-Bombesin Kidney	9.51 SUV-mean Standard Deviation 6.15
Normal Biodistribution of 68Ga-DOTA-Bombesin Lumbar vertebrae	0.75 SUV-mean Standard Deviation 0.28
Normal Biodistribution of 68Ga-DOTA-Bombesin Pancreas	52.02 SUV-mean Standard Deviation 16.74
Normal Biodistribution of 68Ga-DOTA-Bombesin Parotid gland	0.99 SUV-mean Standard Deviation 0.23
Normal Biodistribution of 68Ga-DOTA-Bombesin Sacrum	0.69 SUV-mean Standard Deviation 0.36
Normal Biodistribution of 68Ga-DOTA-Bombesin Spleen	1.62 SUV-mean Standard Deviation 0.49
Normal Biodistribution of 68Ga-DOTA-Bombesin Small bowel	2.40 SUV-mean Standard Deviation 0.57
Normal Biodistribution of 68Ga-DOTA-Bombesin Stomach	2.48 SUV-mean Standard Deviation 0.73
Normal Biodistribution of 68Ga-DOTA-Bombesin Submandibular gland	1.18 SUV-mean Standard Deviation 0.45
Normal Biodistribution of 68Ga-DOTA-Bombesin Thoracic vertebrae	0.91 SUV-mean Standard Deviation 0.32
Normal Biodistribution of 68Ga-DOTA-Bombesin Thyroid	1.31 SUV-mean Standard Deviation 0.29

SECONDARY outcome

Timeframe: Up to 1 week

Population: Includes all participants enrolled.

Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Outcome measures

Outcome measures
Measure	68Ga-DOTA-Bombesin PET/MRI n=10 Participants Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
68Ga-DOTA-Bombesin Feasibility	100 percentage of participants

Adverse Events

68Ga-DOTA-Bombesin PET/MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrei Iagaru, Chief of the Division of Nuclear Medicine and Molecular Imaging

Stanford Healthcare

Phone: 650-725-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place