A Phase 2 interventional study of 68Ga-DOTA-Bombesin and Magnetic Resonance Imaging (MRI) scan in Prostate Carcinoma, sponsored by Stanford University. Completed at 1 site in United States. Open to male participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-04-11.
Sponsored by Stanford University · Phase 2, Interventional, and Diagnostic
This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).
OUTLINE:
Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.
After completion of study, patients are followed up at 24 hours and 1 week.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 10 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA
Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Drug: 68Ga-DOTA-Bombesin · Procedure: Magnetic Resonance Imaging (MRI) scan · Procedure: Positron Emission Tomography (PET) scan
68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is \[4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl\]-acetyl. 68Ga-DOTA-Bombesin is administered intravenously (IV)
Also known as: 68Ga-DOTA RM2, BAY 86-7548, Gallium-68-labeled GRPr Antagonist
Also known as: Nuclear Magnetic Resonance (NMR) scan
Also known as: Proton magnetic resonance spectroscopic imaging
Normal Biodistribution of 68Ga-DOTA-Bombesin
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.
Time frame: 1 hour
68Ga-DOTA-Bombesin Feasibility
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.
Time frame: Up to 1 week
| Milestone | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
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.
| SUV-mean | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| Ascending aorta (blood pool) | 2.28 ± 0.68 |
| Bladder | 121.55 ± 67.45 |
| Brain cortex (frontal lobe) | 0.08 ± 0.04 |
| Cerebellum | 0.10 ± 0.05 |
| Cervical vertebrae | 0.70 ± 0.19 |
| Choroid plexus | 0.25 ± 0.16 |
| Colon | 2.01 ± 0.74 |
| Esophagus | 4.08 ± 1.51 |
| Extra focal uptakes | 12.72 ± 7.77 |
| Femur | 0.34 ± 0.12 |
| Liver | 1.94 ± 0.48 |
| Lung | 0.48 ± 0.16 |
| Gluteal fat | 0.60 ± 0.19 |
| Gluteal muscle | 0.79 ± 0.41 |
| Humerus | 0.53 ± 0.17 |
| Kidney | 9.51 ± 6.15 |
| Lumbar vertebrae | 0.75 ± 0.28 |
| Pancreas | 52.02 ± 16.74 |
| Parotid gland | 0.99 ± 0.23 |
| Sacrum | 0.69 ± 0.36 |
| Spleen | 1.62 ± 0.49 |
| Small bowel | 2.40 ± 0.57 |
| Stomach | 2.48 ± 0.73 |
| Submandibular gland | 1.18 ± 0.45 |
| Thoracic vertebrae | 0.91 ± 0.32 |
| Thyroid | 1.31 ± 0.29 |
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.
| percentage of participants | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| 68Ga-DOTA-Bombesin Feasibility | 100 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Ga-DOTA-Bombesin PET/MRI | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 9 |
| Age, Continuous(years) | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| Median | 73.3 (60.8 to 83.1) |
| Sex: Female, Male(Participants) | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| Female | 0 |
| Male | 10 |
| Region of Enrollment(participants) | 68Ga-DOTA-Bombesin PET/MRI |
|---|---|
| United States | 10 |
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University