A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy
A Pilot Study of 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU or HDR Therapy
Sponsors
Source
Stanford University
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
Yes
Is Fda Regulated Device
Yes
Is Unapproved Device
No
Is Ppsd
No
Brief Summary
This study is being conducted to determine whether the combination of imaging agents 68-Ga
RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound
(HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with
known prostate cancer.
Detailed Description
Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for
evaluation of HIFU or HDR local therapy in patients with known prostate cancer.
Overall Status
Recruiting
Start Date
2019-04-09
Completion Date
2022-10-01
Primary Completion Date
2022-04-01
Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response |
12 months |
Enrollment
10
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Radioactive agent
Arm Group Label
68-Ga RM2+68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2
Other Name
68Ga-DOTA-4-amino-1-carboxymethyl-piperidine-DPhe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2
68Ga-DOTA-Bombesin
BAY86-7548
Intervention Type
Drug
Intervention Name
Description
Radioactive agent
Arm Group Label
68-Ga RM2+68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2
Other Name
DFKZ 11
HBED CC PSMA
Heidelberg compound
Intervention Type
Device
Intervention Name
Description
Investigational software and coils in PET/MR Scan by General Electric Healthcare
Arm Group Label
68-Ga RM2+68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2
Intervention Type
Procedure
Intervention Name
Description
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Arm Group Label
68-Ga RM2+68-Ga PSMA11
68-Ga PSMA11+68-Ga RM2
Other Name
Positron emission tomography (PET)/Magnetic resonance imaging (MRI)
Eligibility
Criteria
Inclusion Criteria:
- Known prostate cancer
- Planned HIFU or HDR local therapy
- Able to provide written consent
- Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG)
/World Health Organization (WHO) equivalent)
Exclusion Criteria:
- Patients not capable of getting PET study due to weight, claustrophobia, or inability
to lay still for the duration of the exam
- Metallic implants (contraindicated for MRI)
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Andrei H Iagaru, MD |
Principal Investigator |
Stanford University |
Overall Contact
Location
Facility |
Status |
Contact |
|
Stanford University Stanford California 94305 United States |
Recruiting |
Location Countries
Country
United States
Verification Date
2019-05-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keyword
Has Expanded Access
No
Condition Browse
Secondary Id
PROS0093
IRB-48213
Number Of Arms
2
Intervention Browse
Mesh Term
Edetic Acid
Arm Group
Arm Group Label
68-Ga RM2+68-Ga PSMA11
Arm Group Type
Experimental
Description
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Arm Group Label
68-Ga PSMA11+68-Ga RM2
Arm Group Type
Experimental
Description
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
May 10, 2019
Study First Submitted Qc
May 10, 2019
Study First Posted
May 14, 2019
Last Update Submitted
May 10, 2019
Last Update Submitted Qc
May 10, 2019
Last Update Posted
May 14, 2019
ClinicalTrials.gov processed this data on May 14, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.