Prostate CarcinomaPhase 2NCT02440308
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
A Phase 2 study testing 68Ga-DOTA-Bombesin, Magnetic Resonance Imaging (MRI) scan and Positron Emission Tomography (PET) scan in people with Prostate Carcinoma, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- 68Ga-DOTA-Bombesin, Magnetic Resonance Imaging (MRI) scan and Positron Emission Tomography (PET) scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 30 Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospitals and Clinics
Stanford, California, 94305
About this study
Official title: 68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- 68Ga-DOTA-Bombesin, Magnetic Resonance Imaging (MRI) scan, Positron Emission Tomography (PET) scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-BombesinDrug
Also called 68Ga-DOTA RM2, BAY 86-7548, Gallium-68-labeled GRPr Antagonist
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)
Magnetic Resonance Imaging (MRI) scanProcedure or surgery
Also called Nuclear Magnetic Resonance (NMR) scan
Positron Emission Tomography (PET) scanProcedure or surgery
Also called Proton magnetic resonance spectroscopic imaging
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTA-Bombesin PET/MRI | Experimental | Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later. Receives: Drug: 68Ga-DOTA-Bombesin; Procedure: Magnetic Resonance Imaging (MRI) scan; Procedure: Positron Emission Tomography (PET) scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440308
- Sponsor's protocol ID
- IRB-32319
- Other IDs
- PROS0069, NCI-2015-00673, P30CA124435
- Status last verified
- Feb 2017
- First submitted
- 1 May 2015
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
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.
PubMed 26659347
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02440308
- Acronym / sponsor ID
- IRB-32319
- Conditions
- Prostate Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2015
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTA-Bombesin PET/MRI | Experimental | Drug: 68Ga-DOTA-Bombesin, Procedure: Magnetic Resonance Imaging (MRI) scan, Procedure: Positron Emission Tomography (PET) scanPatients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTA-BombesinAlso: 68Ga-DOTA RM2, BAY 86-7548, Gallium-68-labeled GRPr Antagonist68Ga-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) | Drug | 68Ga-DOTA-Bombesin PET/MRI |
| Magnetic Resonance Imaging (MRI) scanAlso: Nuclear Magnetic Resonance (NMR) scan | Procedure or surgery | 68Ga-DOTA-Bombesin PET/MRI |
| Positron Emission Tomography (PET) scanAlso: Proton magnetic resonance spectroscopic imaging | Procedure or surgery | 68Ga-DOTA-Bombesin PET/MRI |
Primary outcome
Normal Biodistribution of 68Ga-DOTA-Bombesin
Time frame: 1 hour
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 secondary outcome
68Ga-DOTA-Bombesin Feasibility
Time frame: Up to 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26659347Minamimoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Iagaru principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-DOTA-Bombesin, Magnetic Resonance Imaging (MRI) scan and Positron Emission Tomography (PET) scan in people with Prostate Carcinoma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normal Biodistribution of 68Ga-DOTA-Bombesin (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.