68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
4 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedResults Posted
Study results publicly available
April 11, 2017
CompletedApril 11, 2017
February 1, 2017
3 months
May 1, 2015
February 28, 2017
February 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 hour
Secondary Outcomes (1)
68Ga-DOTA-Bombesin Feasibility
Up to 1 week
Study Arms (1)
68Ga-DOTA-Bombesin PET/MRI
EXPERIMENTALPatients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Interventions
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)
Eligibility Criteria
You may qualify if:
- Provides written informed consent
- Known diagnosis of prostate cancer
- Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) \> 2 ng/mL\]
- Able to remain still for duration of each imaging procedure (about one hour)
You may not qualify if:
- Unable to provide informed consent
- Inability to lie still for the entire imaging time
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
- Metallic implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Stanford University Hospitals and Clinics
Stanford, California, 94305, United States
Related Publications (1)
Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10.
PMID: 26659347DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Andrei Iagaru, Chief of the Division of Nuclear Medicine and Molecular Imaging
- Organization
- Stanford Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru
Stanford University Hospitals and Clinics
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 12, 2015
Study Start
April 1, 2015
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
April 11, 2017
Results First Posted
April 11, 2017
Record last verified: 2017-02